Phase 2
Completed N=63
A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT05424549 ↗
Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber — 0.33; 0.44 score on a scale
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber |
0.33; 0.44 | — |
| PRIMARY Schirmer Test Mean Change From Baseline |
-0.06; -2.54 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05424549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.