NCT05102409Phase 2Completed

An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber

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 completion2021-10-25Actual

Enrollment · participants56Actual

Source updated2025-02-28Last 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%)Drug
Xiidra® (5% lifitegrast ophthalmic solution)Drug

Primary outcomes · main study measures

Read the study measures

measure: Change From Baseline in Ocular Discomfort; description: 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.; timeFrame: 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.; measure: Change From Baseline in Ocular Itching; description: 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.; timeFrame: 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.

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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