Study Evaluating the Safety and Efficacy of AR-15512

Phase 3

Completed

Conditions: Dry Eye Disease

Interventions: Drug: AR 15512 Ophthalmic Solution
Drug: Vehicle

Registration Number: NCT05285644

Lead Sponsor: Aerie Pharmaceuticals

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 465

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 solution 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 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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AR 15512 Ophthalmic Solution (0.003%)	AR 15512 Ophthalmic Solution	0.003% AR 15512 to be administered BID for 90 days. Both eyes will be treated.
Vehicle	Vehicle	AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.

Primary Outcome Measures

Name	Time	Method
Unanesthetized Schirmer test	Day 14	Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score. Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score over time indicates a better outcome.

Secondary Outcome Measures

Name	Time	Method
SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score	Day 7, 14 & 90	Change from Baseline in SANDE score. The SANDE questionnaire consists of two visual analogue scales (VAS), each ranging from 0mm to 100mm to indicate the frequency (from "Rarely" to "All the Time") and severity (from "Very Mild" to "Very Severe") of dry eye symptoms. A higher score indicates greater frequency or severity. Each subject marks both VAS to indicate their level of frequency and severity. The SANDE score is calculated by multiplying the frequency score by the severity score and obtaining the square root. A reduced SANDE score over time indicates a better outcome.
Unanesthetized Schirmer score	Day 7, 28 & 90	Proportion of subjects with ≥ 10 mm increase in score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5-minute period, in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score over time indicates a better outcome.
Ocular Discomfort Score (ODS) - VAS	Day 28 & 90	Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their ocular discomfort. A reduced score over time indicates a better outcome.
Eye Dryness Score (EDS) - VAS	Day 28 & 90	Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their eye dryness. A reduced score over time indicates a better outcome.
Quality of Life VAS	Day 7, 14, 28 & 90	Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "strongly disagree" to "strongly agree") their agreement with the statement "Over the past 3 days my dry eye has interfered with my daily activities and reduced my quality of life". A reduced score over time indicates a better outcome.
Ocular Pain - VAS	Day 90	Change from Baseline Subjects mark a visual analogue scale (VAS) between 0mm to 100mm to indicate (from "no symptom" to "maximal symptom") their ocular discomfort. A reduced score over time indicates a better outcome.
Conjunctival Redness	Day 90	Change from Baseline Investigators or designated sub-Investigators grade redness of the eye on a scale from 0 to 4 (from 0 "normal" to 4 "severe"). A reduced score over time indicates a better outcome.

Trial Locations

Locations (21): Premiere Practice Management, LLC
🇺🇸
Torrance, California, United States
Vision Institute
🇺🇸
Colorado Springs, Colorado, United States
Global Research Management, Inc
🇺🇸
Glendale, California, United States
Segal Drug Trials, Inc.
🇺🇸
Delray Beach, Florida, United States
The Eye Care Group
🇺🇸
Waterbury, Connecticut, United States
Michael Washburn Center for Ophthalmic Research, LLC
🇺🇸
Indianapolis, Indiana, United States
Butchertown Clinical Trials
🇺🇸
Louisville, Kentucky, United States
Central Maine Eye Care
🇺🇸
Lewiston, Maine, United States
Moyes Eye Center
🇺🇸
Kansas City, Missouri, United States
Center for Sight
🇺🇸
Henderson, Nevada, United States
Core, Inc.
🇺🇸
Shelby, North Carolina, United States
Bergstrom Eye Research
🇺🇸
Fargo, North Dakota, United States
Verum Research
🇺🇸
Eugene, Oregon, United States
Advancing Vision Research
🇺🇸
Smyrna, Tennessee, United States
Erie Retina Surgery
🇺🇸
Erie, Pennsylvania, United States
Total Eye Care, PA
🇺🇸
Memphis, Tennessee, United States
Valley Retina Institute, PA
🇺🇸
McAllen, Texas, United States
Austin Clinical Research
🇺🇸
Austin, Texas, United States
Eye Clinics of South Texas
🇺🇸
San Antonio, Texas, United States
R and R Eye Research, LLC
🇺🇸
San Antonio, Texas, United States
Alpine Research Organization Inc.
🇺🇸
Clinton, Utah, United States