Phase 3 N=422 Randomized Triple-blind Treatment

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

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT03879863 ↗

Enrolled (actual)

422

Serious AEs

2.1%

Results posted

Jan 2025

Primary outcome: Primary: Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) — -11.5; -15.0; -17.8; -6.8 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Reproxalap Ophthalmic Solution (0.25%) QID (Drug); Vehicle Ophthalmic Solution QID (Drug); Reproxalap Ophthalmic Solution (0.25%) QID to BID (Drug); Vehicle Ophthalmic Solution QID to BID (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aldeyra Therapeutics, Inc.
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))	-11.5; -15.0; -17.8; -6.8	—
PRIMARY Fluorescein Nasal Region Score (0 = None - 4 = Severe)	-0.47; -0.46; -0.53; -0.46	—

Summary

The RENEW Trial is a Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Adaptive Phase 3 Clinical Trial to Assess the Safety and Efficacy of Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Eligibility Criteria

Inclusion Criteria

Be at least 18 years of age of either gender and any race;
Have a reported history of dry eye for at least 6 months prior to Visit 1;
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

Exclusion Criteria

Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
Have used any eye drops within 2 hours of Visit 1;
Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03879863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.