xml: <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/NCT05964673</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/004549</org_study_id>
      <nct_id>NCT05964673</nct_id>
    </id_info>
    <brief_title>Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women</brief_title>
    <official_title>Effect of Bioptron Light Therapy on Dryness of Eyes in Postmenopausal Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Dry eye disease (DED) is a growing public health concern affecting quality of life and visual&#xD;
        function, with a significant socio-economic impact. It is more prevalent in the females and&#xD;
        is being specifically in the menopausal and postmenopausal age group.&#xD;
  &#xD;
        Bioptron light therapy is efficient in the elimination of allergic reactions, signs and&#xD;
        symptoms of dry eye improving capillary circulation, immunity stimulation, relieving pain and&#xD;
        establishing balance of tissue electromagnetic field&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Around 60 postmenopausal women will be randomly divided into two equal groups, they all&#xD;
        complain from dry eye symptoms, ranging from mild/normal to moderate and severe.&#xD;
  &#xD;
        Group(A): will receive patient education program for four weeks. Group(B): will receive&#xD;
        patient education program and bioptron light therapy for four weeks&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 9, 2023</start_date>
    <completion_date type="Anticipated">November 8, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 19, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dry Eye-Related Quality-Of-Life Score (DEQS)</measure>
      <time_frame>Dry Eye-Related Quality-Of-Life Score will be measured at baseline, and it will be measured again after four weeks</time_frame>
      <description>The Dry Eye-Related Quality-Of-Life Score questionnaire is a 15-item instrument for assessing subjective dry eye symptoms and their effects on activities of daily living within the previous week.&#xD;
  extremely good&#xD;
  very good&#xD;
  good&#xD;
  bad&#xD;
  very bad&#xD;
  extremely bad</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tear Breakup Time (TBUT)</measure>
      <time_frame>Tear Breakup Time will be measured at baseline, and it will be measured again after four weeks</time_frame>
      <description>Tear Breakup Time Is the time interval between a complete blink and the appearance of the first break, discontinuity or dry spot observed in the tear film.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Schirmer's test</measure>
      <time_frame>Schirmer's test will be measured at baseline, and after four weeks</time_frame>
      <description>The Schirmer test score is determined by the length of the moistened area of the strips (using the scale packaged with the strips) and the duration of the measurement in minutes. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postmenopausal Women</condition>
    <arm_group>
      <arm_group_label>education program group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>this group will receive patient education program for four weeks.&#xD;
  limiting screen time&#xD;
  blinking awareness training&#xD;
  keeping the home environment cool and moist&#xD;
  using artificial tears (Hylo®gel) twice daily&#xD;
  contact lens use can preferably be limited,&#xD;
  adding omega-3 poly unsaturated fatty acids in the diet or as dietary supplements.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>bioptron light therapy group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be sitting in a comfortable chair, with their eyes closed, with cleaned eyelids, and occasionally blinking. Bioptron lamp will be lined at an angle of 90°, at a distance from 5 cm to 10 cm, exposure time will be 5 min. Energy is very low, 1 - 2.4 J/cm without thermal effects, energy density is 40mW. Bioptron light is polychrome, wave frequency is from 400 nm (including blue, visible radiation) up to 2000 nm (representing infrared waves)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>bioptron light therapy</intervention_name>
      <description>patients will receive patient education program and bioptron light therapy for four weeks</description>
      <arm_group_label>bioptron light therapy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All participants are postmenopausal women.&#xD;
  &#xD;
            -  Their age above 50 years old&#xD;
  &#xD;
            -  All participants aren't on any systematic therapy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Injuries and previous surgical treatment of eyes&#xD;
  &#xD;
                 -  All patients with diagnosis of chronic blepharitis, meibominitis or any other eye&#xD;
                    infections&#xD;
  &#xD;
                 -  Participants with autoimmune diseases such as Sjögren's syndrome (SS), rheumatoid&#xD;
                    arthritis (RA) and systemic lupus erythematosus (SLE)&#xD;
  &#xD;
                 -  Diabetic participants will be excluded.&#xD;
  &#xD;
                 -  Smokers will be excluded from the study.&#xD;
  &#xD;
                 -  The use of Hormone Replacement Therapy&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sara Ahmed, lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>giza, Egypt, 12511</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sara Ahmed, lecturer</last_name>
      <phone>01063998331</phone>
      <email>Saramagdy87@cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amel Yousef, Professor</last_name>
      <phone>01222726511</phone>
      <email>Amelyousef@pt.cu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cairo University</name>
        <address>
          <city>Cairo,</city>
          <zip>11432</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Amel Yousef, Professor</last_name>
        <phone>01222726511</phone>
        <email>Amelyousef@pt.cu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Rania Ahmed, Assistant professor</last_name>
        <phone>01001593155</phone>
        <email>roni_diamond@yahoo.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ehab Saad, Assistant lecturer</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sara Ahmed, Lecturer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Alaa Mohamed El-Moatasem Mohamed</investigator_full_name>
      <investigator_title>lecturer of physical therapy</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964673
  org study id: P.T.REC/012/004549
  nct id: NCT05964673
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Dry eye disease (DED) is a growing public health concern affecting quality of life and visual
        function, with a significant socio-economic impact. It is more prevalent in the females and
        is being specifically in the menopausal and postmenopausal age group.
  
        Bioptron light therapy is efficient in the elimination of allergic reactions, signs and
        symptoms of dry eye improving capillary circulation, immunity stimulation, relieving pain and
        establishing balance of tissue electromagnetic field
  Around 60 postmenopausal women will be randomly divided into two equal groups, they all
        complain from dry eye symptoms, ranging from mild/normal to moderate and severe.
  
        Group(A): will receive patient education program for four weeks. Group(B): will receive
        patient education program and bioptron light therapy for four weeks
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Dry Eye-Related Quality-Of-Life Score (DEQS)
  time frame: Dry Eye-Related Quality-Of-Life Score will be measured at baseline, and it will be measured again after four weeks
  description: The Dry Eye-Related Quality-Of-Life Score questionnaire is a 15-item instrument for assessing subjective dry eye symptoms and their effects on activities of daily living within the previous week.
  extremely good
  very good
  good
  bad
  very bad
  extremely bad
  measure: Tear Breakup Time (TBUT)
  time frame: Tear Breakup Time will be measured at baseline, and it will be measured again after four weeks
  description: Tear Breakup Time Is the time interval between a complete blink and the appearance of the first break, discontinuity or dry spot observed in the tear film.
  measure: Schirmer's test
  time frame: Schirmer's test will be measured at baseline, and after four weeks
  description: The Schirmer test score is determined by the length of the moistened area of the strips (using the scale packaged with the strips) and the duration of the measurement in minutes. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency.
  arm group label: education program group
  arm group type: No Intervention
  description: this group will receive patient education program for four weeks.
  limiting screen time
  blinking awareness training
  keeping the home environment cool and moist
  using artificial tears (Hylo®gel) twice daily
  contact lens use can preferably be limited,
  adding omega-3 poly unsaturated fatty acids in the diet or as dietary supplements.
  arm group label: bioptron light therapy group
  arm group type: Experimental
  description: Patients will be sitting in a comfortable chair, with their eyes closed, with cleaned eyelids, and occasionally blinking. Bioptron lamp will be lined at an angle of 90°, at a distance from 5 cm to 10 cm, exposure time will be 5 min. Energy is very low, 1 - 2.4 J/cm without thermal effects, energy density is 40mW. Bioptron light is polychrome, wave frequency is from 400 nm (including blue, visible radiation) up to 2000 nm (representing infrared waves)
  intervention type: Device
  intervention name: bioptron light therapy
  description: patients will receive patient education program and bioptron light therapy for four weeks
  arm group label: bioptron light therapy group
  criteria: 
  gender: Female
  minimum age: 50 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Sara Ahmed, lecturer
  role: Principal Investigator
  affiliation: giza, Egypt, 12511
  last name: Sara Ahmed, lecturer
  phone: 01063998331
  email: Saramagdy87@cu.edu.eg
  last name: Amel Yousef, Professor
  phone: 01222726511
  email: Amelyousef@pt.cu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Alaa Mohamed El-Moatasem Mohamed
  investigator title: lecturer of physical therapy