A Phase 2 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Reproxalap Ophthalmic Solution (0.1%) in Dry Eye Syndrome, sponsored by Aldeyra Therapeutics, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 2, Interventional, and Treatment
A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's enrollment of 300 is above 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.
Counted across the registry records on this site, refreshed daily.
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Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Reproxalap Ophthalmic Solution (0.1%)
Drug: Vehicle Ophthalmic Solution
Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
Vehicle Ophthalmic Solution administered for approximately twelve weeks.
Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
Time frame: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.
| Milestone | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| Started | 100 | 100 | 100 |
| Completed | 97 | 88 | 99 |
| Not completed | 3 | 12 | 1 |
Change from baseline comparison of ADX-102 to Vehicle on the Ora Calibra® Discomfort \& 4-Symptom Questionnaire (0 = least, 5 = most) for dryness across all time points. The intervention was administered bilaterally. The Least Squares Mean (Standard Error) was derived from Mixed Model Repeated Measure for change from baseline calculated using baseline score, visit, treatment, and visit-by-treatment interaction.
| units on a scale | Reproxalap (0.25%) | Reproxalap (0.1%) | Vehicle |
|---|---|---|---|
| Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness. | -0.7 ± 0.09 | -0.5 ± 0.08 | -0.4 ± 0.08 |
Collected over The period of time when adverse events were collected was approximately 3 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | 0/100 (0%) | 1/100 (1%) | 93/100 (93%) |
| Reproxalap Ophthalmic Solution (0.1%) | 0/100 (0%) | 1/100 (1%) | 37/100 (37%) |
| Vehicle Ophthalmic Solution | 0/100 (0%) | 0/100 (0%) | 2/100 (2%) |
| Event | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| Angina pectorisCardiac disorders | 1/100 | 0/100 | 0/100 |
| VertigoEar and labyrinth disorders | 0/100 | 1/100 | 0/100 |
| Event | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution |
|---|---|---|---|
| General disorders and administration site conditionsGeneral disorders | 93/100 | 37/100 | 2/100 |
| Age, Categorical(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 58 | 50 | 51 | 159 |
| >=65 years | 42 | 50 | 49 | 141 |
| Sex: Female, Male(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Female | 75 | 76 | 28 | 179 |
| Male | 25 | 24 | 72 | 121 |
| Ethnicity (NIH/OMB)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 1 | 7 |
| Not Hispanic or Latino | 98 | 96 | 99 | 293 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 1 | 2 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 22 | 17 | 17 | 56 |
| White | 77 | 80 | 80 | 237 |
| More than one race | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| United States | 100 | 100 | 100 | 300 |
| Iris Color (Right Eye)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Black | 1 | 1 | 2 | 4 |
| Blue | 15 | 22 | 26 | 63 |
| Brown | 55 | 47 | 46 | 148 |
| Green | 7 | 11 | 10 | 28 |
| Hazel | 22 | 17 | 16 | 55 |
| Gray | 0 | 2 | 0 | 2 |
| Other | 0 | 0 | 0 | 0 |
| Iris Color (Left Eye)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Reproxalap Ophthalmic Solution (0.1%) | Vehicle Ophthalmic Solution | Total |
|---|---|---|---|---|
| Black | 1 | 1 | 2 | 4 |
| Blue | 15 | 22 | 26 | 63 |
| Brown | 55 | 47 | 46 | 148 |
| Green | 7 | 11 | 10 | 28 |
| Hazel | 22 | 17 | 16 | 55 |
| Gray | 0 | 2 | 0 | 2 |
| Other | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jan 2018 to primary completion in Jul 2018, 6 months.
Results were first posted in Feb 2025, 6 years 6 months after primary completion. A results delay was requested in Jul 2019.
Of 75 industry-sponsored phase 2 interventional studies under Dry Eye Syndromes, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 11. This study's 6 months is below that.
Counting every sponsor, half of 90 studies reached it within 7 months; a quarter within 5 and three quarters within 12.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Reproxalap