Status:
COMPLETED
A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- Eighteen (18) to 70 years of age at the time of screening (either gender and any race)
- Ability to provide written informed consent
- Reported history of dry eye for at least 6 months prior to screening
- Reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening
Exclusion
- Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the Investigator, could interfere with study conduct or assessments) at screening
- Contact lens use within 7 days of screening or anticipate using contact lenses during the trial
- Systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period
- Women of childbearing potential (WOCBP) who are pregnant and nursing
- If participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control.
- Known allergy and/or sensitivity to reproxalap or the drug product vehicle
- A condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
- Inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT05424549
Start Date
March 9 2022
End Date
May 9 2022
Last Update
January 15 2025
Active Locations (1)
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1
Cliantha Research
Mississauga, Ontario, Canada, L4W 1A4