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

NCT04498182 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AR-15512-CS201
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 15

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28

  Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 millimeters (mm) (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. This is a co-primary endpoint.

  Baseline (Day 1) (pre-treatment), Day 28

• Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 28

  The Schirmer test measures tear production. Following instillation of topical anesthetic drops, Schirmer strips were placed on the lower eye lids, eyes were closed, and strips remained in place for 5 minutes or until both strips reached a maximum score. The strips were removed, and the amount of wetting was recorded on a scale from 0 mm (no tear production) to 35 mm (maximum tear production). The test was performed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more positive change value indicates a better outcome. One eye (study eye) contributed data to the analysis. This is a co-primary endpoint.

  Baseline (Day 1) (pre-treatment), Day 28

Secondary Outcomes (36)

• Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28

  Day 28

• Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84

  Baseline (Day 1) (pre-treatment), Day 84

• Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84

  Day 84

• Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 84

  Baseline (Day 1) (pre-treatment), Day 84

• Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 84

  Day 84

Study Arms (3)

AR-15512 Ophthalmic Solution Higher Dose

EXPERIMENTAL

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

Drug: AR-15512 Ophthalmic Solution

AR-15512 Ophthalmic Solution Lower Dose

EXPERIMENTAL

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

Drug: AR-15512 Ophthalmic Solution

Vehicle

PLACEBO COMPARATOR

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

Drug: AR-15512 Ophthalmic Solution Vehicle

Interventions

AR-15512 Ophthalmic Solution 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 Higher Dose; AR-15512 Ophthalmic Solution Lower Dose

AR-15512 Ophthalmic Solution Vehicle DRUG

Ophthalmic solution vehicle administered via topical ocular instillation

Vehicle

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (15)

Cornea and Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Midwest Cornea Associates, LLC

Carmel, Indiana, 46290, United States

Location

Michael Washburn Center for Ophthalmic Research, LLC

Indianapolis, Indiana, 46240, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Complete Eye Care of Medina

Hamel, Minnesota, 55340, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research, LLC

Smyrna, Tennessee, 37167, United States

Location

Alpine Research Organization, Inc,

Clinton, Utah, 84015, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Scientific Advisor, Clinical Research and Development
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Scientific Advisor, Clinical Research and Development

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 4, 2020
• Study Start: October 26, 2020
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: August 28, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)