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 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ADX-102-DED-012
• Study Type: interventional
• Target: 422
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Subject-reported Ocular Dryness Score (0 - 100 Visual Analogue Scale (VAS))

  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.

  The efficacy assessment period (Day 1 through 85) was assessed at Weeks 1, 2, 4, 6, 8, 10, and 12; baseline was Day 1.

• Fluorescein Nasal Region Score (0 = None - 4 = Severe)

  Change from baseline comparison of reproxalap to vehicle for fluorescein staining of the nasal region (0 = none - 4 = severe), 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 fluorescein nasal score, treatment arm, visit, and the interaction of treatment arm and visit as fixed effects.

  The efficacy assessment period (Day 15 through 85) was assessed at Weeks 2, 4, 6, 8, 10, and 12; baseline was Day 1.

Study Arms (4)

Reproxalap Ophthalmic Solution (0.25%) QID

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%) QID

Vehicle Ophthalmic Solution QID

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution QID

Reproxalap Ophthalmic Solution (0.25%) QID to BID

EXPERIMENTAL

Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID

Vehicle Ophthalmic Solution QID to BID

PLACEBO COMPARATOR

Drug: Vehicle Ophthalmic Solution QID to BID

Interventions

Reproxalap Ophthalmic Solution (0.25%) QID DRUG

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

Reproxalap Ophthalmic Solution (0.25%) QID

Vehicle Ophthalmic Solution QID DRUG

Vehicle Ophthalmic Solution administered QID for twelve weeks

Vehicle Ophthalmic Solution QID

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

Reproxalap Ophthalmic Solution (0.25%) QID to BID

Vehicle Ophthalmic Solution QID to BID DRUG

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

Vehicle Ophthalmic Solution QID to BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age of either gender and any race;
• Have a reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1

You may not qualify if:

• Have any clinically significant slit-lamp findings at Visit 1, including active blepharitis; meibomian gland dysfunction (MGD); lid margin inflammation; or active ocular allergies that require therapeutic treatment, or, in the opinion of the investigator may interfere with the assessment of the safety or efficacy of reproxalap or vehicle;
• Have or be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) or active ocular inflammation at Visit 1;
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have used any eye drops within 2 hours of Visit 1;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Have used ophthalmic cyclosporine or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
• Have used temporary or permanent punctal plugs within 30 days prior to Visit 1 or anticipate their use during the study period

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Operations
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: April 16, 2019
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: January 23, 2025
• Results First Posted: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)