NCT03879863Phase 3Completed

The RENEW Trial: A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of 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 completion2019-10-04Actual

Enrollment · participants422Actual

Source updated2025-01-23Last 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%) QIDDrug
Vehicle Ophthalmic Solution QIDDrug
Reproxalap Ophthalmic Solution (0.25%) QID to BIDDrug
Vehicle Ophthalmic Solution QID to BIDDrug

Primary outcomes · main study measures

Read the study measures

measure: 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: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.; measure: Fluorescein Nasal Region Score (0 = None - 4 = Severe); description: Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), 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 fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.; timeFrame: The efficacy assessment period (Day 15 through 85) was assessed at Weeks 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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