A Phase 2/3 interventional study of Reproxalap Ophthalmic Solution (0.25%) and Vehicle Opthalmic Solution in Dry Eye and Dry Eye Syndromes, sponsored by Aldeyra Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Aldeyra Therapeutics, Inc. · Phase 2/3, Interventional, and Treatment
The TRANQUILITY Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2/3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 329 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Aldeyra Therapeutics, Inc. is the lead sponsor of 33 studies on the registry; 1 is open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 22 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Opthalmic Solution
Reproxalap Ophthalmic Solution (0.25%) administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
Time frame: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.
Schirmer Test Change From Baseline After the First Dose on Day 1
Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.
Time frame: The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.
| Milestone | Reproxalap Ophthalmic Solution (0.25%) | Vehicle |
|---|---|---|
| Started | 164 | 163 |
| Completed | 162 | 160 |
| Not completed | 2 | 3 |
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
| units on a scale | Reproxalap Ophthalmic Solution (0.25%) | Vehicle |
|---|---|---|
| Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber | 0.185 ± 0.0233 | 0.156 ± 0.0229 |
Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.
| millimeters | Reproxalap Ophthalmic Solution (0.25%) | Vehicle |
|---|---|---|
| Schirmer Test Change From Baseline After the First Dose on Day 1 | 5.9 ± 0.53 | 3.5 ± 0.53 |
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 255 scale ( 0 = none, 255 = maximum), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
| units on a scale | Reproxalap Ophthalmic Solution (0.25%) | Vehicle |
|---|---|---|
| Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber Using Computer Automated Grading | 0.309 ± 0.2160 | 0.962 ± 0.2121 |
The number of subject eyes that are schirmer test responders (eyes with 10 millimeters or more increase from baseline) using a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome.
| eyes | Reproxalap Ophthalmic Solution (0.25%) | Vehicle |
|---|---|---|
| Number of Subject Eyes That Are Schirmer Test Responders (Eyes 10 Millimeters or More Increase From Baseline) | 125 | 64 |
Collected over The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | 0/164 (0%) | 0/164 (0%) | 118/164 (72%) |
| Vehicle | 0/163 (0%) | 0/163 (0%) | 2/163 (1.2%) |
| Event | Reproxalap Ophthalmic Solution (0.25%) | Vehicle |
|---|---|---|
| General disorders and administration site conditionsGeneral disorders | 118/164 | 2/163 |
Safety population
| Age, Categorical(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 87 | 82 | 169 |
| >=65 years | 77 | 81 | 158 |
| Sex: Female, Male(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| Female | 118 | 120 | 238 |
| Male | 46 | 43 | 89 |
| Ethnicity (NIH/OMB)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 12 | 22 |
| Not Hispanic or Latino | 154 | 151 | 305 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 12 | 12 | 24 |
| Black or African American | 18 | 22 | 40 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| White | 132 | 127 | 259 |
| Other | 0 | 0 | 0 |
| Multiple | 1 | 1 | 2 |
| Region of Enrollment(participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| United States | 164 | 163 | 327 |
| Iris Color (Right Eye)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| Black | 1 | 4 | 5 |
| Blue | 48 | 44 | 92 |
| Brown | 75 | 73 | 148 |
| Hazel | 24 | 18 | 42 |
| Green | 14 | 23 | 37 |
| Gray | 2 | 1 | 3 |
| Other | 0 | 0 | 0 |
| Iris Color (Left Eye)(Participants) | Reproxalap Ophthalmic Solution (0.25%) | Vehicle | Total |
|---|---|---|---|
| Black | 1 | 4 | 5 |
| Blue | 48 | 44 | 92 |
| Brown | 75 | 73 | 148 |
| Hazel | 24 | 18 | 42 |
| Green | 14 | 23 | 37 |
| Gray | 2 | 1 | 3 |
| Other | 0 | 0 | 0 |
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Aldeyra Therapeutics, Inc.