Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment

Study Overview
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Brief Summary
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The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Detailed Description
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This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).

Official Title
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A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: BRM421
* Drug: Placebo


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 history of dry eye for at least 6 months prior to enrollment; Have a history of use of eye drops Exclusion Criteria: Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters; Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1; Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study; Have used any eye drops within 2 hours of Visit 1; Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months; Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BRM421 Ophthalmic Solution<br>A topical solution of BRIM421 ophthalmic drops | Drug: BRM421<br>* The active control with BRM421 solution<br>|
| Placebo Comparator: Placebo<br>A vehicle ophthalmic drops | Drug: Placebo<br>* The vehicle solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14 | Corneal staining was performed to grade the degree of corneal epithelial cell injury as measured by fluorescence using slit-lamp examination. Ora Calibra® Scale from 0 to 4 with the use of half grade (0.5) increments, where grade 0 = None and 4 = Severe. Regions assessed were the central, superior, inferior, temporal, and nasal. Total corneal staining score was the sum of all five regions. Analyses were for study eye only. | 2 weeks | 
| Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire | Ocular dryness from the Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire was assessed at the subject level in regard to how both eyes felt. The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire was used, which included rating the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranged from 0 to 5, where 0 = None and 5 = Worst. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS) | Visual analog scale (VAS) was measured by asking subjects to rate each ocular symptom due to ocular dryness by placing a vertical mark on a horizontal line of length 100 mm to indicate the level of discomfort where 0 mm = No Discomfort and 100 mm = Maximal Discomfort. Symptoms assessed were burning/stinging, itching, foreign body sensation, blurred vision, eye dryness, photophobia, and pain. | 2 weeks |