A Study to Assess the Safety and Efficacy of IC265 Ophthalmic Solution for Dry Eye in Adult Participants

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle in participants with signs and symptoms dry eye disease.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: IC265 Ophthalmic Solution 1%
* Drug: Placebo Ophthalmic Solution (Vehicle)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age; Provide written informed consent Have a reported or documented history of dry eye for at least 6 months prior to Visit 1 Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1 Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one symptom at Visits 1 and 2 Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2 Have a pre-CAE conjunctival redness score ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) at Visits 1 and 2 Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions at Visits 1 and 2 Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at Visits 1 and 2 Demonstrate a response to the CAE at Visits 1 and 2 as defined by: Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE exposure Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) Note: a subject cannot have an ocular discomfort score of 4 at time = 0) Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment Have any clinically significant (CS) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the Investigator may interfere with study parameters Have worn contact lenses within 48 hours prior to Visit 1 or anticipate using contact lenses during the study Have laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to Visit 1; or have any ocular surgical procedure scheduled to be conducted during the study period Have had any surgeries of the ocular surface or lid in the past 6 months Have a history of lacrimal duct obstruction in either eye within 12 months prior to Visit 1 Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1 or anticipate their use during the study period Have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate any such event at any time during the study period Use any of the following treatments in the period indicated before Visit 1 or anticipate their use at any time during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC265 Ophthalmic Solution 1%<br>1 drop will be instilled in each eye twice daily. | Drug: IC265 Ophthalmic Solution 1%<br>* 1 drop will be instilled in each eye twice a day<br>|
| Placebo Comparator: Placebo Ophthalmic Solution (Vehicle)<br>1 drop will be instilled in each eye twice daily. | Drug: Placebo Ophthalmic Solution (Vehicle)<br>* 1 drop will be instilled in each eye twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score | 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). | Days 15, 43 and 85 | 
| Ocular discomfort and dry eye symptoms | 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. | Days 15, 43 and 85 | 
| Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score | 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). | Days 15, 43 and 85 | 
| Tear film break-up time (TFBUT) | 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. | Days 15, 43 and 85 | 
| Conjunctival Redness | 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 | Days 15, 43 and 85 and mean change from Day 1 to Day 85 | 
| Ocular Surface Disease Index (OSDI)© | Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100. | Days 15, 43 and 85 | 
| Schirmer's test |  | Days 15, 43 and 85 | 
| Ocular discomfort during CAE |  | Days 43 and 85 | 
| Daily Diary Symptom Score |  | Daily Diary completed from Day 1 through Day 85 |