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

Aldeyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Dry Eye

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03879863

ADX-102-DED-012

Details and patient eligibility

About

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

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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406 participants in 4 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%) QID

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%) QID

Vehicle Ophthalmic Solution QID

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution QID

Reproxalap Ophthalmic Solution (0.25%) QID to BID

Experimental group

Treatment:

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

Vehicle Ophthalmic Solution QID to BID

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution QID to BID