AR-15512 Ophthalmic Solution for Dry Eye

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Vision Institute, Colorado Springs, CO
Dry Eye+3 More
AR-15512 Ophthalmic Solution - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Dry Eye
  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Day 7, 14, 28 & 90

Day 14
Unanesthetized Schirmer test
Day 28 & 90
Eye Dryness Score (EDS) - VAS
Ocular Discomfort Score (ODS) - VAS
Day 7
Quality of Life VAS
Day 7, 14, 90
SANDE (Symptom Assessment iN Dry Eye) Questionnaire Score
Day 7
Unanesthetized Schirmer score
Day 90
Conjunctival Redness
Ocular Pain - VAS

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

AR-15512 Ophthalmic Solution (0.003%)
1 of 2
Vehicle
1 of 2
Experimental Treatment
Non-Treatment Group

460 Total Participants · 2 Treatment Groups

Primary Treatment: AR-15512 Ophthalmic Solution · Has Placebo Group · Phase 3

AR-15512 Ophthalmic Solution (0.003%)
Drug
Experimental Group · 1 Intervention: AR-15512 Ophthalmic Solution · Intervention Types: Drug
Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 7, 14, 28 & 90
Closest Location: Vision Institute · Colorado Springs, CO
Photo of colorado 1Photo of colorado 2Photo of colorado 3
2017First Recorded Clinical Trial
0 TrialsResearching Dry Eye
6 CompletedClinical Trials

Who is running the clinical trial?

Aerie PharmaceuticalsLead Sponsor
37 Previous Clinical Trials
7,753 Total Patients Enrolled
Michelle Senchyna, PhDStudy DirectorAerie Pharma
3 Previous Clinical Trials
1,099 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 30 years of age or older.
Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS.
You have a corrected visual acuity of at least +0.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.