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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

NCT03916042 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2025-03-03

Study results available
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Summary

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

Conditions

  • Dry Eye

Interventions

DRUG

Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID

Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks

DRUG

Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID

Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks

Sponsors & Collaborators

  • Aldeyra Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-23
Primary Completion
2019-11-22
Completion
2019-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916042 on ClinicalTrials.gov