Safety and Efficacy of BRM421 for Dry Eye Syndrome Treatment
- Registration Number
- NCT04343287
- Lead Sponsor
- BRIM Biotechnology Inc.
- Brief Summary
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
This is a multi-center, double-masked, randomized, placebo-controlled, phase 2/3 study with approximately 200 subjects. (around 100 subjects per treatment arm).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BRM421 Ophthalmic Solution BRM421 A topical solution of BRIM421 ophthalmic drops Placebo Placebo A vehicle ophthalmic drops
- Primary Outcome Measures
Name Time Method Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire 2 weeks 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.
Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14 2 weeks 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.
- Secondary Outcome Measures
Name Time Method Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS) 2 weeks 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.
Trial Locations
- Locations (4)
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Midwest Cornea Associates, LLC
🇺🇸Indianapolis, Indiana, United States
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States
Total Eye Care
🇺🇸Memphis, Tennessee, United States