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
Overview
- Phase
- Phase 2
- Intervention
- BRM421
- Conditions
- Dry Eye Syndrome
- Sponsor
- BRIM Biotechnology Inc.
- Enrollment
- 220
- Locations
- 8
- Primary Endpoint
- Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
- Status
- Completed
- Last Updated
- yesterday
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
BRM421 Ophthalmic Solution
A topical solution of BRIM421 ophthalmic drops
Intervention: BRM421
Placebo
A vehicle ophthalmic drops
Intervention: Placebo
Outcomes
Primary Outcomes
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Time Frame: 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
Time Frame: 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.
Ocular Sign: Change From Baseline in Total Corneal Staining Score to Day 14
Time Frame: change from baseline to 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. Total corneal staining score was the sum of all three regions (Inferior, Central and Superior), the score range is from 0 (minimum) to 12 (maximum).
Ocular Symptom: Change From Baseline in Patient-Reported Ocular Dryness Score to Day 14, Using Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire
Time Frame: change from baseline to 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.
Secondary Outcomes
- Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 14, Using Visual Analog Scale (VAS)(2 weeks)
- Eye Dryness: Change From Baseline in Patient-Reported Ocular Symptom to Day 8, Using Visual Analog Scale (VAS)(change from baseline to 1 week)