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

NCT ID: NCT04498182

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2021-07-17

Brief Summary

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.

Detailed 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.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AR-15512 Ophthalmic Solution Higher Dose

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

Group Type: EXPERIMENTAL

AR-15512 Ophthalmic Solution

Intervention Type: DRUG

Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)

AR-15512 Ophthalmic Solution Lower Dose

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

Group Type: EXPERIMENTAL

AR-15512 Ophthalmic Solution

Intervention Type: DRUG

Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)

Vehicle

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

Group Type: PLACEBO_COMPARATOR

AR-15512 Ophthalmic Solution Vehicle

Intervention Type: DRUG

Ophthalmic solution vehicle administered via topical ocular instillation

Interventions

AR-15512 Ophthalmic Solution

Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)

Intervention Type: DRUG

AR-15512 Ophthalmic Solution Vehicle

Ophthalmic solution vehicle administered via topical ocular instillation

Intervention Type: DRUG

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scientific Advisor, Clinical Research and Development

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, United States

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Midwest Cornea Associates, LLC

Carmel, Indiana, United States

Michael Washburn Center for Ophthalmic Research, LLC

Indianapolis, Indiana, United States

The Eye Care Institute

Louisville, Kentucky, United States

Andover Eye Associates

Andover, Massachusetts, United States

Andover Eye Associates

Raynham, Massachusetts, United States

Complete Eye Care of Medina

Hamel, Minnesota, United States

Moyes Eye Center

Kansas City, Missouri, United States

Vita Eye Clinic

Shelby, North Carolina, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Advancing Vision Research, LLC

Smyrna, Tennessee, United States

Alpine Research Organization, Inc,

Clinton, Utah, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AR-15512-CS201

Identifier Type: -

Identifier Source: org_study_id