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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Aldeyra Therapeutics, Inc.
Study ID
NCT03879863
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Reproxalap Ophthalmic Solution (0.25%) QID — DRUG
    Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks
  • Vehicle Ophthalmic Solution QID — DRUG
    Vehicle Ophthalmic Solution administered QID for twelve weeks
  • Reproxalap Ophthalmic Solution (0.25%) QID to BID — DRUG
    Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks
  • Vehicle Ophthalmic Solution QID to BID — DRUG
    Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks

Study Details

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

Key Dates

Start date
Apr 16, 2019
Status verified
Jan 2025
Primary completion
Oct 4, 2019
Completion
Oct 4, 2019

Study Design

Enrollment
422 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Reproxalap Ophthalmic Solution (0.25%) QID
  • Placebo Comparator: Vehicle Ophthalmic Solution QID
  • Experimental: Reproxalap Ophthalmic Solution (0.25%) QID to BID
  • Placebo Comparator: Vehicle Ophthalmic Solution QID to BID

Primary Outcome Measure

Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS)) [ Time Frame: The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Eye Research FoundationNewport BeachCalifornia92663-

Find similar trials in Newport Beach, CA

By research site
Eye Research Foundation· Newport Beach, CA

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