NCT03916042

A Multi-Center, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial of Reproxalap to Assess the Safety and Efficacy in Subjects With Dry Eye Disease

Completed Phase 2 Results posted Last updated 3 March 2025

What this trial tests

Phase 2 trial testing Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID in Dry Eye in 206 participants. Completed in 22 November 2019.

Timeline

23 April 2019

Primary endpoint
22 November 2019

22 November 2019

Quick facts

Lead sponsor	Aldeyra Therapeutics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	206
Start date	23 April 2019
Primary completion	22 November 2019
Estimated completion	22 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID — full drug profile →
• Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID — full drug profile →

Conditions studied

• Dry Eye — all drugs for Dry Eye →

Sponsor

Aldeyra Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) Primary · Efficacy assessment period (Day 1 through 85) - assessed at Weeks 1, 2, 4, 6, 8, 10, and 12. Baseline was Day 1.

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.

Group	Value	95% CI
Reproxalap (0.25% Novel Formulation)	-16.0	± 2.20
Vehicle	-9.1	± 2.18

Adverse events — posted to ClinicalTrials.gov

Time frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately three months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Reproxalap (0.25% Novel Formulation)

Serious: 1/102 (1%)

Deaths: 0/102

Vehicle

Serious: 1/104 (1%)

Deaths: 0/104

Serious adverse events (2 terms)

Reaction	System	Reproxalap (0.25% Novel Fo…	Vehicle
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Cellulitis	Infections and infestations	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Reproxalap (0.25% Novel Fo…	Vehicle
General disorders and administration site conditions	General disorders	—	—
Visual acuity reduced	Eye disorders	—	—

Most-reported serious reactions: Pleural effusion, Cellulitis.

Data from ClinicalTrials.gov NCT03916042 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.