A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Phase 3
Completed
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Vehicle ophthalmic solution
- Registration Number
- NCT06424444
- Lead Sponsor
- Aldeyra Therapeutics, Inc.
- Brief Summary
A Multicenter, Phase 3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Environment Exposure Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 421
Inclusion Criteria
- at least 18 years of age;
- written informed consent and sign the Health Information Portability and Accountability Act (HIPAA) form;
- history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Exclusion Criteria
- ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
- contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the trial;
- eye drops within 2 hours of Visit 1;
- laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- topical ocular cyclosporine, lifitegrast, corticosteroid, or any other topical ocular prescription medication within 90 days of Visit 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reproxalap Ophthalmic Solution (0.25%) Reproxalap ophthalmic solution (0.25%) - Vehicle Ophthalmic Solution Vehicle ophthalmic solution -
- Primary Outcome Measures
Name Time Method Subject-reported ocular discomfort score over Week 1 to Week 6 From Day -14 to Day 43 Measured using a 0 - 100 visual analog scale where 0 is "no discomfort" and 100 is "maximal discomfort"
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Reproxalap's PDE4 inhibition in treating dry eye disease?
How does 0.25% Reproxalap compare to cyclosporine A or lifitegrast in dry eye disease efficacy?
Which biomarkers correlate with response to PDE4 inhibitors like Reproxalap in dry eye subtypes?
What adverse events are associated with PDE4 inhibitor ophthalmic solutions in phase 3 trials?
Are there combination therapies involving Reproxalap and anti-inflammatory agents for dry eye disease?
Trial Locations
- Locations (1)
Core, Inc.
🇺🇸Shelby, North Carolina, United States
Core, Inc.🇺🇸Shelby, North Carolina, United States