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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03879863

Collaborator

(none)

406

Enrollment

Location

Arms

5.6

Actual Duration (Months)

72.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Drug: Reproxalap Ophthalmic Solution (0.25%) QID Drug: Vehicle Ophthalmic Solution QID Drug: Reproxalap Ophthalmic Solution (0.25%) QID to BID Drug: Vehicle Ophthalmic Solution QID to BID	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

406 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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 Reproxalap 0.25% Ophthalmic Solution Compared to Vehicle in Subjects With Dry Eye Disease

Actual Study Start Date :

Apr 16, 2019

Actual Primary Completion Date :

Oct 4, 2019

Actual Study Completion Date :

Oct 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reproxalap Ophthalmic Solution (0.25%) QID	Drug: Reproxalap Ophthalmic Solution (0.25%) QID Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks
Placebo Comparator: Vehicle Ophthalmic Solution QID	Drug: Vehicle Ophthalmic Solution QID Vehicle Ophthalmic Solution administered QID for twelve weeks
Experimental: Reproxalap Ophthalmic Solution (0.25%) QID to BID	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
Placebo Comparator: Vehicle Ophthalmic Solution QID to BID	Drug: Vehicle Ophthalmic Solution QID to BID Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks

Outcome Measures

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Research Foundation	Newport Beach	California	United States	92663

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aldeyra Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03879863

Other Study ID Numbers:

ADX-102-DED-012

First Posted:

Mar 19, 2019

Last Update Posted:

Dec 7, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Pharmaceutical Solutions

Ophthalmic Solutions

Study Results

No Results Posted as of Dec 7, 2020