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

Phase 3

Completed

Conditions: Dry Eye Disease

Interventions: Drug: 0.003% AR-15512 ophthalmic solution
Drug: AR-15512 vehicle ophthalmic solution

Registration Number: NCT05493111

Lead Sponsor: Aerie Pharmaceuticals

Brief Summary: This will be a Phase 3, 12-month, multicenter, vehicle-controlled, double-masked, randomized Phase 3 study conducted at approximately 10 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of a Baseline Visit (Day 1) as well as visits on Days 14, Day 90, Day 180, Day 270, and Day 365 (Study Exit). In addition, there will be dispensing visits on Days 45, 135, 225, and 315.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 275

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.
Schirmer test score with or without topical anesthesia as specified in the protocol within 1 year of the Baseline visit.
Total ocular surface staining score as specified in the protocol at 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.

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 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.003% AR-15512	0.003% AR-15512 ophthalmic solution	0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days
AR-15512 Vehicle	AR-15512 vehicle ophthalmic solution	AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days

Primary Outcome Measures

Name	Time	Method
Heart Rate	Time Frame: Day 1, 14, 90, 180, 270 & 365	Change from Baseline Each subjects heart rate will be measured using manual or automated methods and recorded in bpm. Minimal change from the start of the study indicates a better outcome.
Intraocular pressure (IOP)	Day 1, 14, 90, 180, 270 & 365	Change from baseline A small tonometer device will be pressed against the surface of the eye to determine the pressure inside the eye. The pressure will be recorded in mmHg. Lower scores indicate a better outcome.
Dilated fundus exam	Day 1, 14, 90, 180, 270 & 365	Change from baseline The back of the eyes will be dilated, examined and graded based on standard clinical scales and recorded as normal or abnormal. Minimal change from the start of the study indicates a better outcome
Adverse Events	Day 1, 14, 90, 180, 270 & 365	Incidence of Adverse Events Subjects will be verbally asked by clinic staff to report any changes to any aspect of their health (systemic or ocular) at each study visit. A low incidence indicates a better outcome.
Blood Pressure	Day 1, 14, 90, 180, 270 & 365	Change from baseline Each subjects systolic and diastolic blood pressure will be measured using an appropriate sphygmomanometer and will be recorded in mmHg. Minimal change from the start of the study indicates a better outcome.
Endothelial cell counts	Day 1 and 365	Change from baseline Specular microscopy will be used to measure cells in the central cornea to determine cell density which will be recorded. Minimal change from the start of the study indicates a better outcome.
LogMAR Visual Acuity	Day 1, 14, 90, 180, 270 & 365	Change from baseline Each subject's vision will be assessed using an eye chart and the score will be recorded as the number of letters read. If a subject wears glasses, these will be worn during the test. Minimal change from the start of the study indicates a better outcome.
Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity	Day 1 & 365	Change from baseline Change from baseline Each subject's vision will be assessed using a standardized eye chart and ETDRS testing procedure. The score will be recorded as the number of letters read. Minimal change from the start of the study indicates a better outcome.
Total ocular staining	Day 1, 14, 90, 180, 270 & 365	Change from baseline Dye is applied to the surface of the eye and the amount of dye that remains after several minutes will viewed through a microscope and graded using a standardized scale (0-5). Lower scores indicate a better outcome.
Hematology, chemistry, and urinalysis	Day 1, 180 & 365	Change from baseline A small volume of blood and urine will be collected from each subject and these samples will be sent to a laboratory to evaluate each subjects overall health. Values for each assessment will be recorded in their respective clinical units. Minimal change from the start of the study indicates a better outcome.
Biomicroscopy	Day 1, 14, 90, 180, 270 & 365	Change from baseline With the aid of a microscope, the front part of the eyes and eyelids and the surface of the cornea will be examined and graded based on standard clinical scales and recorded as normal or abnormal. Minimal change from the start of the study indicates a better outcome.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (10): Arizona Eye Institute
🇺🇸
Sun City, Arizona, United States
Arizona Eye Center
🇺🇸
Chandler, 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