Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

Aerie Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05360966

AR-15512-CS302

Details and patient eligibility

About

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit).

Enrollment: 467 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 30 years of age or older at the Screening visit
• Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test
• Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS
• Corrected visual acuity (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits

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
• Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study
• Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study
• Use of any topical ocular anti-inflammatory medication within 30 days prior to the Screening visit or anticipated use during the study (e.g., ocular cyclosporine [Restasis®, Cequa™], lifitegrast [Xiidra®], or any other prescription ophthalmic product for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents
• Use of Tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Screening visit or anticipated use during the study
• Use of medications for the treatment of severe DED and/or Meibomian gland disease such as oral pilocarpine, oral cevimeline, oral macrolides, oral tetracyclines, oral tetracycline derivatives, and oral retinoids within 30 days prior to the Screening visit or anticipated use during the study.
• Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) less than 14 days prior to the Screening visit or a change in dosage is anticipated during the study.
• Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study.
• Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study
• History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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467 participants in 2 patient groups, including a placebo group

AR-15512 Ophthalmic Solution (0.003%)

Experimental group

Description:

0.003% AR-15512 to be administered BID for 90 days. Both eyes will be treated.

Treatment:

Drug: AR-15512 Ophthalmic Solution

Vehicle

Placebo Comparator group

Description:

AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.

Treatment:

Drug: Vehicle