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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879863
• Other study ID #: ADX-102-DED-012
• Status: Completed
• Phase: Phase 3
• Start date: April 16, 2019
• Est. completion date: October 4, 2019

Study information

• Verified date: December 2020
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
United States	Eye Research Foundation	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject-reported ocular dryness score (0 - 100 VAS)	The method of assessment is subject-reported ocular dryness score (0 - 100 VAS)	Efficacy assessment period (Week 2 through Week 12)
Primary	Fluorescein nasal region score (Ora Calibra® scale)	The method of assessment is Fluorescein nasal region score (Ora Calibra® scale)	Efficacy assessment period (Week 2 through Week 12)
Secondary	Fluorescein staining	The method of assessment for this outcome is the Fluorescein staining Ora Calibra®	Efficacy assessment period (Week 2 through Week 12)
Secondary	Unanesthetized Schirmer's Test	The method of assessment for this outcome is the Schirmer test strip.	Efficacy assessment period (Week 2 through Week 12)