A Phase 2 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Xiidra® (5% lifitegrast ophthalmic solution) in Dry Eye, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Aldeyra Therapeutics, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 24 (83%) have results posted.
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Exclusion Criteria:
Single dose
Drug: Reproxalap Ophthalmic Solution (0.25%)
Single dose
Drug: Xiidra® (5% lifitegrast ophthalmic solution)
Reproxalap Ophthalmic Solution (0.25%) dosed once
Xiidra® (5% lifitegrast ophthalmic solution) dosed once
Change From Baseline in Ocular Discomfort
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
Change From Baseline in Ocular Itching
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
Time frame: The efficacy assessment period was approximately every 5 minutes during a 45-minute dry eye chamber. Baseline was prior to dosing for each treatment period.
| Milestone | Lifitegrast, Reproxalap |
|---|---|
| Started | 56 |
| Completed | 54 |
| Not completed | 2 |
Ocular discomfort (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a mixed model repeated measures (MMRM) analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
| score on a scale | Reproxalap | Lifitegrast |
|---|---|---|
| Change From Baseline in Ocular Discomfort | 1.35 ± 0.21 | 2.07 ± 0.25 |
Ocular itching (0 = none, 10 = extremely severe) was reported by patients in a dry eye chamber. Change from baseline was analyzed using a MMRM analysis, with baseline as a covariate, and treatment and intra-chamber time point as factors.
| score on a scale | Reproxalap | Lifitegrast |
|---|---|---|
| Change From Baseline in Ocular Itching | 0.93 ± 0.21 | 1.54 ± 0.25 |
Collected over One day for each intervention. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap | 0/54 (0%) | 0/54 (0%) | 40/54 (74.1%) |
| Lifitegrast | 0/56 (0%) | 0/56 (0%) | 12/56 (21.4%) |
| Event | Reproxalap | Lifitegrast |
|---|---|---|
| General DisordersGeneral disorders | 40/54 | 6/56 |
| Nervous System DisordersNervous system disorders | 0/54 | 6/56 |
Enrolled subjects
| Age, Continuous(years) | Lifitegrast, Reproxalap |
|---|---|
| Mean | 47.9 ± 12.4 |
| Sex: Female, Male(Participants) | Lifitegrast, Reproxalap |
|---|---|
| Female | 36 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | Lifitegrast, Reproxalap |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 47 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Lifitegrast, Reproxalap |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 12 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 33 |
| More than one race | 5 |
| Unknown or Not Reported | 0 |
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Studies of the drug tested here: Reproxalap