Phase 2
Completed N=56
An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber
Source: ClinicalTrials.gov NCT05102409 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Change From Baseline in Ocular Discomfort — 1.35; 2.07 score on a scale
Summary
An Exploratory, Single-Center, Double-Masked, Crossover Clinical Trial to Assess Safety and Tolerability of 0.25% Reproxalap Ophthalmic Solution Compared to Xiidra® in Subjects with Dry Eye Disease in a Dry Eye Chamber
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ocular Discomfort |
1.35; 2.07 | — |
| PRIMARY Change From Baseline in Ocular Itching |
0.93; 1.54 | — |
Eligibility Criteria
Inclusion Criteria
- Eighteen (18) to70 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 Visit 1.
Exclusion Criteria
- Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1.
- Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial.
- 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 (NCT05102409). 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.