<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04453033</url>
  </required_header>
  <id_info>
    <org_study_id>CSP-PD 01</org_study_id>
    <nct_id>NCT04453033</nct_id>
  </id_info>
  <brief_title>DB RCT for Specialized Phototherapy in Parkinson's Disease.</brief_title>
  <acronym>LIGHT-PD</acronym>
  <official_title>Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PhotoPharmics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PhotoPharmics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pivotal study to determine whether light therapy can improve non-motor and motor&#xD;
      function in Parkinson's disease, on top of current best medical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Six month double blind, randomized controlled study with virtual clinic visits at baseline,&#xD;
      week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with&#xD;
      a stand that allows the device to be angled towards the participant's face. The light is to&#xD;
      be used each evening in the home for 1 hour, while the participant watches TV, eats dinner,&#xD;
      reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary&#xD;
      Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary&#xD;
      endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease&#xD;
      Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in&#xD;
      Parkinson's. Participants will be assessed via online videoconferences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 2023</start_date>
  <completion_date type="Anticipated">November 2025</completion_date>
  <primary_completion_date type="Anticipated">July 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a six-month, randomized, double-blind, controlled, parallel group study with visits at screening, baseline, weeks 13 and 26, and blinded coordinator calls throughout the study for safety and efficacy assessments. This study will use a remote trial design, which will allow participants to be recruited nationally and evaluated centrally using video conferencing. All study participants will have their eligibility assessed and confirmed by a study coordinator and a PD specialist (primary investigator). Participants will complete the secondary outcome measures, which are Patient Response Outcomes (PRO's), and will be assisted by a blinded coordinator to ensure completeness of answers. A blinded rater will conduct the Primary Outcome Measure as well as the MDS-UPDRS. All assessments will be conducted by video at Baseline, Week 13, and Week 26 visits.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The purpose of the study is to determine whether one intensity is more effective than other intensities of light, and it is unknown whether one intensity will be more effective. Thus, subjects will receive a study device which looks identical to the other devices and which produces the same bandwidths (color), but which may produce a different intensity of that color of light. A Device Technician, separate from the trial, will assist the participants in the device setup. Participants will be instructed not to disclose any aspects of their device. All study staff will be masked. A separate Medical Monitor may become unmasked if the participants experience a serious adverse event that may be related to the therapy. However, this is unlikely, since the therapy is considered safe.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Parkinson's Disease Questionnaire-39 (PDQ-39)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2</measure>
    <time_frame>26 weeks</time_frame>
    <description>MDS-UPDRS Part 1: Non-motor impact of experiences of daily living. Part I has 13 questions, the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65, with higher scores representing worse severity.&#xD;
MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire. Each question = 0-4, range = 0-65. with higher scores representing worse severity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.</description>
  </other_outcome>
  <other_outcome>
    <measure>Beck Depression Inventory -II (BDI-II)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The Beck Depression Inventory (BDI) is a 21-question multiple choice inventory to measure the severity of depression. Each question is scored on a scale value of 0 to 3. The cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Beck Anxiety Scale (BAI)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). Input from a caregiver to the participant is acceptable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The SCOPA-SLEEP is a frequency measure scale to assess the character and quantify the various aspects of sleep problems in Parkinson's disease. The SCOPA-Sleep consists of 13 items, including information about the use of sleeping tablets. Questions range from 0 to 4 in severity, (Question 7, Quality of Sleep, ranges from 0-7). A higher total score indicates more severe sleep problems.</description>
  </other_outcome>
  <other_outcome>
    <measure>Cogstate Brief Battery (CBB)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The CogState Brief Battery (CBB) is a brief, computer-administered cognitive test battery that consists of four cognitive tasks that measure psychomotor function, attention, working memory and memory. The administration, scoring and reporting is automated and highly standardized. Each task in the battery is constructed using playing cards as stimuli with the test taker required to answer only &quot;yes&quot; or &quot;no&quot; on each trial in accord with a simple rule. A higher score indicates better cognition. The CBB will be used at Baseline and again at Week 26. An efficacy analysis may be conducted at the end of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Fatigue Severity Scale (FSS)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The Fatigue Severity Scale is a 9-item, self-report scale, which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer</description>
  </other_outcome>
  <other_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA will be used at screening, mainly for characterization purposes and to assist the site investigators in their decisions to include participants in the trial. Higher scores indicate better cognitive function, while a score below 26 may indicate mild cognitive impairment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The MDS-UPDRS Part 3 is the motor examination section of the MDS-UPDRS. It is completed by the Evaluator. Part 3 evaluates speech, tremor, bradykinesia, rigidity, spontaneity of movement, gait, and balance. Because rigidity (3.3) and postural stability (3.12) cannot be measured remotely, a modified version, which omits these questions will be used. The same rater will evaluate the same participants whenever possible, and at the same time of day. Raters must be certified in the use of the MDS-UPDRS.</description>
  </other_outcome>
  <other_outcome>
    <measure>Movement Disorders Society Unified Parkinson's Disease Rating Scale, Part 4 (MDS-UPDRS 4)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The MDS-UPDRS Part 4 assesses motor complications the person with Parkinson's has experienced over the past week. Part 4 covers time of the waking day spent with dyskinesias, and impact of dyskinesias. It also assesses motor fluctuations, including: Time spent in OFF state, functional impact of fluctuations, predictability of OFF episodes, and painful OFF state dystonia. Scores in each category are rated from &quot;0&quot; (normal) to &quot;4&quot; (severe).</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroQol-5 Dimensions (EQ-5D-5L)</measure>
    <time_frame>26 weeks</time_frame>
    <description>The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The instrument comprises a short descriptive system questionnaire covering five areas which assess quality of life issues, and a visual analogue scale (EQ VAS) that provides a simple descriptive profile of a respondent's health state. The 5L refers to five levels (0-4) of increasing severity for each question.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Investigational Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Device</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Celeste Specialized Phototherapy Device</intervention_name>
    <description>Ocular phototherapy light panel</description>
    <arm_group_label>Control Device</arm_group_label>
    <arm_group_label>Investigational Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD&#xD;
        Society Brain Bank Criteria for the Diagnosis of PD&#xD;
&#xD;
        Responsiveness to dopaminergic medication, as judged by the rater, and have been using&#xD;
        treatment for at least the past 1 year&#xD;
&#xD;
        Relatively good eyesight as attested to by participants (Corrective lenses of at least&#xD;
        20/60)&#xD;
&#xD;
        Stable levodopa and other anti-PD medications for at least 28 days prior to screening -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Diagnosis of an atypical Parkinsonian syndrome&#xD;
&#xD;
        More than 50% of the waking day spent in the OFF state&#xD;
&#xD;
        More than 25% (&gt;4 hours/day) of bothersome dyskinesias&#xD;
&#xD;
        An anticipated need for a change in dopamine replacement therapy, concomitant medications,&#xD;
        OTC/supplements, or other alternative therapies during the participant's involvement in the&#xD;
        investigation&#xD;
&#xD;
        History of previous light therapy use for PD&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ray Dorsey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dan Adams</last_name>
    <phone>8014947804</phone>
    <email>dan.adams@photopharmics.com</email>
  </overall_contact>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication and FDA submission, PhotoPharmics intends to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04453033
org study id: CSP-PD 01
nct id: NCT04453033
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This is a pivotal study to determine whether light therapy can improve non-motor and motor
      function in Parkinson's disease, on top of current best medical treatment.
Six month double blind, randomized controlled study with virtual clinic visits at baseline,
      week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with
      a stand that allows the device to be angled towards the participant's face. The light is to
      be used each evening in the home for 1 hour, while the participant watches TV, eats dinner,
      reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary
      Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary
      endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease
      Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in
      Parkinson's. Participants will be assessed via online videoconferences.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a six-month, randomized, double-blind, controlled, parallel group study with visits at screening, baseline, weeks 13 and 26, and blinded coordinator calls throughout the study for safety and efficacy assessments. This study will use a remote trial design, which will allow participants to be recruited nationally and evaluated centrally using video conferencing. All study participants will have their eligibility assessed and confirmed by a study coordinator and a PD specialist (primary investigator). Participants will complete the secondary outcome measures, which are Patient Response Outcomes (PRO's), and will be assisted by a blinded coordinator to ensure completeness of answers. A blinded rater will conduct the Primary Outcome Measure as well as the MDS-UPDRS. All assessments will be conducted by video at Baseline, Week 13, and Week 26 visits.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The purpose of the study is to determine whether one intensity is more effective than other intensities of light, and it is unknown whether one intensity will be more effective. Thus, subjects will receive a study device which looks identical to the other devices and which produces the same bandwidths (color), but which may produce a different intensity of that color of light. A Device Technician, separate from the trial, will assist the participants in the device setup. Participants will be instructed not to disclose any aspects of their device. All study staff will be masked. A separate Medical Monitor may become unmasked if the participants experience a serious adverse event that may be related to the therapy. However, this is unlikely, since the therapy is considered safe.
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
time frame: 26 weeks
description: The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.
measure: Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2
time frame: 26 weeks
description: MDS-UPDRS Part 1: Non-motor impact of experiences of daily living. Part I has 13 questions, the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65, with higher scores representing worse severity.
MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire. Each question = 0-4, range = 0-65. with higher scores representing worse severity.
measure: Epworth Sleepiness Scale (ESS)
time frame: 26 weeks
description: The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.
measure: Beck Depression Inventory -II (BDI-II)
time frame: 26 weeks
description: The Beck Depression Inventory (BDI) is a 21-question multiple choice inventory to measure the severity of depression. Each question is scored on a scale value of 0 to 3. The cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.
measure: Beck Anxiety Scale (BAI)
time frame: 26 weeks
description: The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). Input from a caregiver to the participant is acceptable.
measure: Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep)
time frame: 26 weeks
description: The SCOPA-SLEEP is a frequency measure scale to assess the character and quantify the various aspects of sleep problems in Parkinson's disease. The SCOPA-Sleep consists of 13 items, including information about the use of sleeping tablets. Questions range from 0 to 4 in severity, (Question 7, Quality of Sleep, ranges from 0-7). A higher total score indicates more severe sleep problems.
measure: Cogstate Brief Battery (CBB)
time frame: 26 weeks
description: The CogState Brief Battery (CBB) is a brief, computer-administered cognitive test battery that consists of four cognitive tasks that measure psychomotor function, attention, working memory and memory. The administration, scoring and reporting is automated and highly standardized. Each task in the battery is constructed using playing cards as stimuli with the test taker required to answer only "yes" or "no" on each trial in accord with a simple rule. A higher score indicates better cognition. The CBB will be used at Baseline and again at Week 26. An efficacy analysis may be conducted at the end of the study.
measure: Fatigue Severity Scale (FSS)
time frame: 26 weeks
description: The Fatigue Severity Scale is a 9-item, self-report scale, which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
measure: Montreal Cognitive Assessment (MoCA)
time frame: 26 weeks
description: The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA will be used at screening, mainly for characterization purposes and to assist the site investigators in their decisions to include participants in the trial. Higher scores indicate better cognitive function, while a score below 26 may indicate mild cognitive impairment.
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified)
time frame: 26 weeks
description: The MDS-UPDRS Part 3 is the motor examination section of the MDS-UPDRS. It is completed by the Evaluator. Part 3 evaluates speech, tremor, bradykinesia, rigidity, spontaneity of movement, gait, and balance. Because rigidity (3.3) and postural stability (3.12) cannot be measured remotely, a modified version, which omits these questions will be used. The same rater will evaluate the same participants whenever possible, and at the same time of day. Raters must be certified in the use of the MDS-UPDRS.
measure: Movement Disorders Society Unified Parkinson's Disease Rating Scale, Part 4 (MDS-UPDRS 4)
time frame: 26 weeks
description: The MDS-UPDRS Part 4 assesses motor complications the person with Parkinson's has experienced over the past week. Part 4 covers time of the waking day spent with dyskinesias, and impact of dyskinesias. It also assesses motor fluctuations, including: Time spent in OFF state, functional impact of fluctuations, predictability of OFF episodes, and painful OFF state dystonia. Scores in each category are rated from "0" (normal) to "4" (severe).
measure: EuroQol-5 Dimensions (EQ-5D-5L)
time frame: 26 weeks
description: The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The instrument comprises a short descriptive system questionnaire covering five areas which assess quality of life issues, and a visual analogue scale (EQ VAS) that provides a simple descriptive profile of a respondent's health state. The 5L refers to five levels (0-4) of increasing severity for each question.
arm group label: Investigational Device
arm group type: Active Comparator
description: The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light.
arm group label: Control Device
arm group type: Sham Comparator
description: The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device.
intervention type: Device
intervention name: Celeste Specialized Phototherapy Device
description: Ocular phototherapy light panel
arm group label: Control Device
arm group label: Investigational Device
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ray Dorsey, MD
role: Principal Investigator
affiliation: University of Rochester
last name: Dan Adams
phone: 8014947804
email: dan.adams@photopharmics.com
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Yes
ipd description: In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication and FDA submission, PhotoPharmics intends to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.