A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: AR-15512 Ophthalmic Solution Vehicle; Drug: AR-15512 Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04498182

AR-15512-CS201

Details and patient eligibility

About

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.

Full description

At the end of the Screening Visit, all qualified subjects will be assigned to administer AR-15512 vehicle twice a day to both eyes for 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to receive AR-15512 0.0014% (lower dose), AR-15512 0.003% (higher dose) or AR-15512 vehicle administered as 1 drop in each eye twice daily for 84 days.

This study will utilize a Controlled Adverse Environment (CAE) chamber, which serves to (1) minimize the factors that could impact the evaluation (temperature, humidity, and airflow) and (2) stress the ocular surface in a safe, standardized, controlled, and reproducible manner. Subjects will be exposed to the CAE for approximately 90 minutes during each CAE visit. Subjects will be exposed to the CAE at the Screening and Baseline visits as well as on Day 28 (Visit 4) and Day 84 (Visit 5). Efficacy endpoints will be evaluated pre- and post- exposure to the CAE.

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Enrollment: 369 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Previous history of dry eye disease (DED) within the previous 6 months;
• Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
• Signs and symptoms of DED at the Screening and Baseline visits;
• Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
• Current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
• Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
• Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
• Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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369 participants in 3 patient groups, including a placebo group

AR-15512 Ophthalmic Solution Higher Dose

Experimental group

Description:

AR-15512 Ophthalmic Solution 0.003%, one drop in each eye twice daily for 84 days. Both eyes will be treated.

Treatment:

Drug: AR-15512 Ophthalmic Solution

AR-15512 Ophthalmic Solution Lower Dose

Experimental group

Description:

AR-15512 Ophthalmic Solution 0.0014%, one drop in each eye twice daily for 84 days. Both eyes will be treated.

Treatment:

Drug: AR-15512 Ophthalmic Solution

Vehicle

Placebo Comparator group

Description:

AR-15512 Ophthalmic Solution Vehicle, one drop in each eye twice daily for 84 days. Both eyes will be treated.

Treatment:

Drug: AR-15512 Ophthalmic Solution Vehicle