Phase 2 N=158 Randomized Quadruple-blind Treatment

A Clinical Trial to Assess Subjects With Dry Eye Disease.

Dry Eye

Bottom Line

View on ClinicalTrials.gov: NCT04971031 ↗

Enrolled (actual)

158

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber — 0.066; 0.183 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Reproxalap Ophthalmic Solution (0.25%) (Drug); Vehicle Ophthalmic Solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aldeyra Therapeutics, Inc.
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Conjunctival Redness Assessed Via Digital Photography Over 90 Minutes in the Dry Eye Chamber	0.066; 0.183	—
PRIMARY Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))	-5.7; -3.8	—
PRIMARY Schirmer Test Change From Baseline After the First Dose on Day 1	4.2; 2.1	—

Summary

A Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 2 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Eligibility Criteria

Inclusion Criteria

18 years of age (either gender and any race);
Reported history of dry eye for at least 6 months prior to Visit 1;
Reported history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria

Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
Eye drop use within 2 hours of Visit 1;
Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04971031). 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.