NCT03404115Phase 2Completed

A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution 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 completion2018-07-11Actual

Enrollment · participants300Actual

Source updated2025-02-06Last 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 Syndrome

Treatments or interventions studied

Reproxalap Ophthalmic Solution (0.25%)Drug
Reproxalap Ophthalmic Solution (0.1%)Drug
Vehicle Ophthalmic SolutionDrug

Primary outcomes · main study measures

Read the study measures

measure: Efficacy of ADX-102 on the Ora Calibra® Discomfort & 4-Symptom Questionnaire for Dryness.; description: 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.; timeFrame: Efficacy assessment period (Day 1 through Day 85) - assessed on Days 1, 15, 29, 57, and 85.

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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