NCT03916042Phase 2Completed

A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease

Study sponsor: Aldeyra Therapeutics, Inc. · ALDX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2019-11-22Actual

Enrollment · participants206Actual

Source updated2025-03-03Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Dry Eye

Treatments or interventions studied

Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BIDDrug
Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BIDDrug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)); description: Change from baseline comparison of reproxalap to vehicle for subject-reported Ocular Dryness Score VAS (0 = no discomfort - 100 = maximal discomfort), where a higher 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 calculated using baseline score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.; timeFrame: Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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