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Study Evaluating the Safety and Efficacy of AR-15512 (COMET-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Aerie Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 7, 14, 28 & 90
Awards & highlights
Pivotal Trial

Summary

This trial tests a new treatment for dry eye disease. It involves patients who suffer from dry eye disease and aims to see if the new treatment can increase eye moisture or reduce inflammation.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 7, 14, 28 & 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7, 14, 28 & 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Unanesthetized Schirmer test
Secondary study objectives
Conjunctival Redness
Eye Dryness Score (EDS) - VAS
Ocular Discomfort Score (ODS) - VAS
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AR 15512 Ophthalmic Solution (0.003%)Experimental Treatment1 Intervention
0.003% AR 15512 to be administered BID for 90 days. Both eyes will be treated.
Group II: VehiclePlacebo Group1 Intervention
AR-15512 vehicle to be administered BID for 90 days. Both eyes will be treated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AR 15512 Ophthalmic Solution
2022
Completed Phase 3
~470

Find a Location

Who is running the clinical trial?

Aerie PharmaceuticalsLead Sponsor
38 Previous Clinical Trials
7,861 Total Patients Enrolled
Susan RowanStudy DirectorAerie Pharmaceuticals
1 Previous Clinical Trials
49 Total Patients Enrolled
Michelle Senchyna, PhDStudy DirectorAerie Pharmaceuticals
3 Previous Clinical Trials
1,111 Total Patients Enrolled
~130 spots leftby Dec 2025
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