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

Phase 3

Completed

• Conditions: Dry Eye
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%) QID; Drug: Vehicle Ophthalmic Solution QID; Drug: Vehicle Ophthalmic Solution QID to BID; Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID

• Registration Number: NCT03879863
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Study Start: 2019-04-16
• Primary Completion: 2019-10-04
• Study Completion: 2019-10-04
• Status Verified: 2020-12
• Disposition First Submitted: 2020-12-02
• Disposition First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Disposition First Posted: 2020-12-07
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

• 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

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Exclusion Criteria

• 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 lifitigrast 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%) QID	Reproxalap Ophthalmic Solution (0.25%) QID	-
Vehicle Ophthalmic Solution QID	Vehicle Ophthalmic Solution QID	-
Vehicle Ophthalmic Solution QID to BID	Vehicle Ophthalmic Solution QID to BID	-
Reproxalap Ophthalmic Solution (0.25%) QID to BID	Reproxalap Ophthalmic Solution (0.25%) QID to BID	-

Primary Outcome Measures

Name	Time	Method
Fluorescein nasal region score (Ora Calibra® scale)	Efficacy assessment period (Week 2 through Week 12)	The method of assessment is Fluorescein nasal region score (Ora Calibra® scale)
Subject-reported ocular dryness score (0 - 100 VAS)	Efficacy assessment period (Week 2 through Week 12)	The method of assessment is subject-reported ocular dryness score (0 - 100 VAS)

Secondary Outcome Measures

Name	Time	Method
Fluorescein staining	Efficacy assessment period (Week 2 through Week 12)	The method of assessment for this outcome is the Fluorescein staining Ora Calibra®
Unanesthetized Schirmer's Test	Efficacy assessment period (Week 2 through Week 12)	The method of assessment for this outcome is the Schirmer test strip.

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States