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/NCT05992922</url>
    </required_header>
    <id_info>
      <org_study_id>23-110-0002</org_study_id>
      <nct_id>NCT05992922</nct_id>
    </id_info>
    <brief_title>A Study to Assess Adverse Events and Change in Disease Activity of IC265 Ophthalmic Solution for Dry Eye in Adult Participants</brief_title>
    <official_title>A Phase 2, Single-Center, Randomized, Double- Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution 1% in Subjects Diagnosed With Dry Eye Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Iacta Pharmaceuticals</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Iacta Pharmaceuticals</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle&#xD;
        in participants with signs and symptoms dry eye disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score</measure>
      <time_frame>Days 15, 43 and 85</time_frame>
      <description>The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ocular discomfort and dry eye symptoms</measure>
      <time_frame>Days 15, 43 and 85</time_frame>
      <description>Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score</measure>
      <time_frame>Days 15, 43 and 85</time_frame>
      <description>The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tear film break-up time (TFBUT)</measure>
      <time_frame>Days 15, 43 and 85</time_frame>
      <description>With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are &gt; 2 seconds apart and are each &lt; 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Conjunctival Redness</measure>
      <time_frame>Days 15, 43 and 85 and mean change from Day 1 to Day 85</time_frame>
      <description>Conjunctival Redness at Visits 3, 4 (pre-CAE, post-CAE, and pre- to post- CAE), and 5 (pre-CAE, post-CAE, and pre- to post-CAE), and mean change from baseline Visit 2 (Day 1) pre-CAE to Visit 5 (Day 85) pre-CAE</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ocular Surface Disease Index (OSDI)©</measure>
      <time_frame>Days 15, 43 and 85</time_frame>
      <description>Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Schirmer's test</measure>
      <time_frame>Days 15, 43 and 85</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Ocular discomfort during CAE</measure>
      <time_frame>Days 43 and 85</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Daily Diary Symptom Score</measure>
      <time_frame>Daily Diary completed from Day 1 through Day 85</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Dry Eye Syndromes</condition>
    <arm_group>
      <arm_group_label>IC265 Ophthalmic Solution 1%</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 drop will be instilled in each eye twice daily.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Ophthalmic Solution (Vehicle)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>1 drop will be instilled in each eye twice daily.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IC265 Ophthalmic Solution 1%</intervention_name>
      <description>1 drop will be instilled in each eye twice a day</description>
      <arm_group_label>IC265 Ophthalmic Solution 1%</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo Ophthalmic Solution (Vehicle)</intervention_name>
      <description>1 drop will be instilled in each eye twice a day</description>
      <arm_group_label>Placebo Ophthalmic Solution (Vehicle)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be at least 18 years of age;&#xD;
  &#xD;
            -  Provide written informed consent&#xD;
  &#xD;
            -  Have a reported or documented history of dry eye for at least 6 months prior to Visit&#xD;
               1&#xD;
  &#xD;
            -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months&#xD;
               of Visit 1&#xD;
  &#xD;
            -  Report a score of ≥ 2 on a Ocular Discomfort &amp; 4-symptom questionnaire in at least one&#xD;
               symptom at Visits 1 and 2&#xD;
  &#xD;
            -  Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2&#xD;
  &#xD;
            -  Have a pre-CAE conjunctival redness score ≥ 1 according to the Conjunctival Redness&#xD;
               for Dry Eye Scale in at least one eye at Visits 1 and 2&#xD;
  &#xD;
            -  Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g.&#xD;
               inferior, superior, or central) at Visits 1 and 2&#xD;
  &#xD;
            -  Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the&#xD;
               inferior, superior, and central regions at Visits 1 and 2&#xD;
  &#xD;
            -  Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the&#xD;
               temporal and nasal regions at Visits 1 and 2&#xD;
  &#xD;
            -  Demonstrate a response to the CAE at Visits 1 and 2 as defined by:&#xD;
  &#xD;
                 1. Having at least a ≥1 point increase in fluorescein staining in the inferior&#xD;
                    region in at least one eye following CAE exposure&#xD;
  &#xD;
                 2. Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in&#xD;
                    at least one eye during CAE exposure (if a subject has an ocular discomfort&#xD;
                    rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating&#xD;
                    of 4 for two consecutive measurements for that eye) Note: a subject cannot have&#xD;
                    an ocular discomfort score of 4 at time = 0)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have any clinically significant slit lamp findings at Visit 1 that may include active&#xD;
               blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or&#xD;
               active ocular allergies that require therapeutic treatment&#xD;
  &#xD;
            -  Have any clinically significant (CS) posterior chamber findings, or a history of such&#xD;
               findings/disorders, that may include exudative (i.e., wet) age-related macular&#xD;
               degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular&#xD;
               hypertension, or any other retinal or optic nerve disease/disorder that require&#xD;
               therapeutic treatment and/or in the opinion of the Investigator may interfere with&#xD;
               study parameters&#xD;
  &#xD;
            -  Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact&#xD;
               lenses during the study&#xD;
  &#xD;
            -  Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal&#xD;
               refractive surgery and/or any other ocular surgical procedure within 12 months prior&#xD;
               to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the&#xD;
               study period&#xD;
  &#xD;
            -  Have had any surgeries of the ocular surface or lid in the past 6 months&#xD;
  &#xD;
            -  Have a history of lacrimal duct obstruction in either eye within 12 months prior to&#xD;
               Visit 1&#xD;
  &#xD;
            -  Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or&#xD;
               anticipate their use during the study period&#xD;
  &#xD;
            -  Have permanent punctal plugs inserted or removed - including falling out - or have had&#xD;
               surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such&#xD;
               event at any time during the study period&#xD;
  &#xD;
            -  Use any of the following treatments in the period indicated before Visit 1 or&#xD;
               anticipate their use at any time during the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Iacta Pharma</last_name>
      <phone>714-330-8532</phone>
      <email>sj@iactapharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Iacta Selected Site</name>
        <address>
          <city>Andover</city>
          <state>Massachusetts</state>
          <zip>01810</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharmaceutical Solutions</mesh_term>
      <mesh_term>Ophthalmic Solutions</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05992922
  org study id: 23-110-0002
  nct id: NCT05992922
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle
        in participants with signs and symptoms dry eye disease.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
  time frame: Days 15, 43 and 85
  description: The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
  measure: Ocular discomfort and dry eye symptoms
  time frame: Days 15, 43 and 85
  description: Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.
  measure: Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score
  time frame: Days 15, 43 and 85
  description: The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent).
  measure: Tear film break-up time (TFBUT)
  time frame: Days 15, 43 and 85
  description: With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are > 2 seconds apart and are each < 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged.
  measure: Conjunctival Redness
  time frame: Days 15, 43 and 85 and mean change from Day 1 to Day 85
  description: Conjunctival Redness at Visits 3, 4 (pre-CAE, post-CAE, and pre- to post- CAE), and 5 (pre-CAE, post-CAE, and pre- to post-CAE), and mean change from baseline Visit 2 (Day 1) pre-CAE to Visit 5 (Day 85) pre-CAE
  measure: Ocular Surface Disease Index (OSDI)©
  time frame: Days 15, 43 and 85
  description: Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100.
  measure: Schirmer's test
  time frame: Days 15, 43 and 85
  measure: Ocular discomfort during CAE
  time frame: Days 43 and 85
  measure: Daily Diary Symptom Score
  time frame: Daily Diary completed from Day 1 through Day 85
  arm group label: IC265 Ophthalmic Solution 1%
  arm group type: Experimental
  description: 1 drop will be instilled in each eye twice daily.
  arm group label: Placebo Ophthalmic Solution (Vehicle)
  arm group type: Placebo Comparator
  description: 1 drop will be instilled in each eye twice daily.
  intervention type: Drug
  intervention name: IC265 Ophthalmic Solution 1%
  description: 1 drop will be instilled in each eye twice a day
  arm group label: IC265 Ophthalmic Solution 1%
  intervention type: Drug
  intervention name: Placebo Ophthalmic Solution (Vehicle)
  description: 1 drop will be instilled in each eye twice a day
  arm group label: Placebo Ophthalmic Solution (Vehicle)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Iacta Pharma
  phone: 714-330-8532
  email: sj@iactapharma.com
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  mesh term: Pharmaceutical Solutions
  mesh term: Ophthalmic Solutions
  sharing ipd: No