MedTrace Logo

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

NCT03879863 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2025-01-23

Study results available
· View outcomes & findings →

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

Conditions

  • Dry Eye

Interventions

DRUG

Reproxalap Ophthalmic Solution (0.25%) QID

Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks

DRUG

Vehicle Ophthalmic Solution QID

Vehicle Ophthalmic Solution administered QID for twelve weeks

DRUG

Reproxalap Ophthalmic Solution (0.25%) QID to BID

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

DRUG

Vehicle Ophthalmic Solution 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
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2019-10-04
Completion
2019-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03879863 on ClinicalTrials.gov