A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512

NCT ID: NCT05493111

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-02-28

Brief Summary

The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.

Detailed Description

At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study.

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

0.003% AR-15512

0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days

Group Type: EXPERIMENTAL

0.003% AR-15512 ophthalmic solution

Intervention Type: DRUG

Active ingredients administered via topical ocular instillation

AR-15512 Vehicle

AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days

Group Type: PLACEBO_COMPARATOR

AR-15512 vehicle ophthalmic solution

Intervention Type: DRUG

Inactive ingredients administered via topical ocular instillation

Interventions

0.003% AR-15512 ophthalmic solution

Active ingredients administered via topical ocular instillation

Intervention Type: DRUG

AR-15512 vehicle ophthalmic solution

Inactive ingredients administered via topical ocular instillation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
• Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
• Corrected visual acuity as specified in the protocol at the Baseline visit.
• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.

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 disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
• Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
• Use of medications as specified in the protocol.
• Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scientific Advisor, CRD

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Arizona Eye Center

Chandler, Arizona, United States

Arizona Eye Institute

Sun City, Arizona, United States

Global Research Management

Glendale, California, United States

Macy Eye Center

Los Angeles, California, United States

Eye Research Foundation

Newport Beach, California, United States

Shultz Vision

Northridge, California, United States

SightMD

Manhasset, New York, United States

University Eye Specialists

Maryville, Tennessee, United States

Piedmont Eye Center

Lynchburg, Virginia, United States

Periman Eye Institute

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AR-15512-LTSS

Identifier Type: -

Identifier Source: org_study_id