The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

Aldeyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Dry Eye

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05062330

ADX-102-DED-023

Details and patient eligibility

About

The TRANQUILITY 2 Trial: Multi-Center Randomized, Double-Masked, Parallel Design, Vehicle-Controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of 0.25% Reproxalap Ophthalmic Solution Compared to Vehicle in Subjects with Dry Eye Disease

Enrollment: 361 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
• Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
• Eye drop use within 2 hours of Visit 1;
• Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution use within 90 days of Visit 1;
• Be receiving systemic corticosteroid therapy (not including inhaled corticosteroids) within 14 days of Visit 1 or anticipate such therapy throughout the study period;
• Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
• Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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361 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days

Experimental group

Treatment:

Drug: Reproxalap Ophthalmic Solution (0.25%)

Vehicle Ophthalmic Solution administered 7 times over two consecutive days

Placebo Comparator group

Treatment:

Drug: Vehicle Ophthalmic Solution