At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 63 enrolled
Drug / intervention
Reproxalap Ophthalmic Solution (0.25%) +1 moredrug
Likely dose
Reproxalap 0.25% ophthalmic solution, 6 doses administered over 2 consecutive daysAI-extracted
Key inclusion· 4
- ✓Age 18 to 70 years at screening
- ✓Reported history of dry eye disease for at least 6 months before screening
- ✓Reported use of eye drops for dry eye disease 2 weeks to 6 months before screening
- ✓Ability to provide written informed consent
Key exclusion· 5
- ✕Ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease that could interfere with study conduct or assessments
- ✕Contact lens use within 7 days of screening or anticipated use during the trial
- ✕Systemic corticosteroid or immunomodulatory therapy (excluding inhaled corticosteroids) within 60 days of screening or planned use during the study
- ✕Known allergy or sensitivity to reproxalap or vehicle components
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease
In Brief
A Phase 2 clinical trial evaluating Reproxalap Ophthalmic Solution (0.25%) and Vehicle Ophthalmic Solution for Dry Eye Syndromes. Completed, enrolled 63 participants across 1 site.
Detailed Summary
A Randomized, Double-Masked, Vehicle-Controlled Crossover Clinical Trial to Assess Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
Enrollment StartMar 2022
Primary CompletionMay 2022
First PostedJun 2022
TodayJul 2026
First PostedJun 21, 2022
Enrollment StartMar 9, 2022
Primary CompletionMay 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.0 years ago
Interventions
Reproxalap Ophthalmic Solution (0.25%)drug
Reproxalap Ophthalmic Solution (0.25%) dosed six times over two consecutive days
Vehicle Ophthalmic Solutiondrug
Vehicle Ophthalmic Solution dosed six times over two consecutive days