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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7, 14, 28 & 90

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

Do I qualify?Apply below to find out

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian institutions participating in this research?

"To lessen the burden of travel, patients are encouraged to choose a clinical trial site from the 19 locations closest to them. There are presently recruiting patients out of these locations, which include McAllen, Fargo and Louisville."

Answered by AI

How does AR 15512 Ophthalmic Solution impact those who use it?

"AR 15512 Ophthalmic Solution is in Phase 3 of clinical trials, thus there is some evidence of its efficacy and it has undergone multiple rounds of safety testing-- scoring it a 3 on our team's safety scale."

Answered by AI

Are researchers looking for new participants for this trial?

"That is correct, the clinical trial detailed on clinicaltrials.gov is still recruiting patients. First posted on May 9th, 2022, and edited most recently on September 16th, this study is looking for 460 participants at 19 different enrolment sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating the Safety and Efficacy of AR-15512

2022. "Study Evaluating the Safety and Efficacy of AR-15512". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05285644.