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AR 15512 Ophthalmic Solution for Dry Eye Syndrome (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

COMET-2 Trial Summary

This trial is for a new dry eye disease treatment. It will compare the new treatment to a fake (vehicle) treatment. The trial will have ~20 sites in the US and will last ~3 months.

Eligible Conditions
  • Dry Eye Syndrome

COMET-2 Trial 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

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

COMET-2 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
~155 spots leftby Jun 2025
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