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AR-15512 for Dry Eye Syndrome (COMET-4 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 1, 14, 90, 180, 270 & 365
Awards & highlights

COMET-4 Trial Summary

This trial will test a new treatment for dry eye disease (DED) in 10 US sites over 12 months. Subjects will visit regularly and be randomly assigned to a treatment or control group.

Who is the study for?
This trial is for adults over 18 with a history of Dry Eye Disease (DED) within the last year, who have certain levels of eye surface staining and tear production. Participants should be in good general and ocular health but cannot use contact lenses or any topical eye treatments for DED or glaucoma recently.Check my eligibility
What is being tested?
The study tests AR-15512 Ophthalmic Solution against a placebo (vehicle) over 12 months to evaluate its long-term safety in treating DED. Patients will visit clinics at set intervals after starting treatment to monitor effects.See study design
What are the potential side effects?
While specific side effects are not listed, potential side effects may include irritation, discomfort, or redness in the eyes; changes in vision; or other ocular symptoms related to the application of ophthalmic solutions.

COMET-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 14, 90, 180, 270 & 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 14, 90, 180, 270 & 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Ultrasound Biomicroscopy
Blood Pressure
+8 more
Other outcome measures
Accumulation Ratio (Rcmax)
Minimum Plasma Concentration (Cmin)
Time to Last Detectable Concentration (Tlast)
+2 more

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391
6%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Acute tonsillitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Blepharal pigmentation
1%
Pharyngitis
1%
Eye irritation
1%
Cataract
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker

COMET-4 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 365 days. Both eyes will be treated.
Group II: VehiclePlacebo Group1 Intervention
AR-15512 vehicle to be administered BID for 365 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
8,051 Total Patients Enrolled
Michelle Senchyna, PhDStudy DirectorAerie Pharma
3 Previous Clinical Trials
1,301 Total Patients Enrolled

Media Library

AR-15512 Ophthalmic Solution (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05493111 — Phase 3
Dry Eye Syndrome Research Study Groups: Vehicle, AR-15512 Ophthalmic Solution (0.003%)
Dry Eye Syndrome Clinical Trial 2023: AR-15512 Ophthalmic Solution Highlights & Side Effects. Trial Name: NCT05493111 — Phase 3
AR-15512 Ophthalmic Solution (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05493111 — Phase 3

Frequently Asked Questions

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

Are there any risks associated with using AR-15512 Ophthalmic Solution (0.003%)?

"AR-15512 Ophthalmic Solution (0.003%) has been given a safety score of 3 by our analysts at Power. This is because in addition to supporting efficacy, there is also extensive data backing its safety as it has gone through multiple rounds of testing."

Answered by AI

How many research participants will be recruited for this experiment?

"To complete this clinical trial, 270 individuals that fit the pre-determined criteria are required. Those interested can inquire at Macy Eye Center in Los Angeles or Global Research Management in Glendale."

Answered by AI

Are there different clinical trial sites in operation across Canada?

"There are a total of 9 sites enrolling patients for this clinical trial. The locations nearest to Los Angeles are Glendale and Newport Beach. There are also other centres in 9 additional cities. If you choose to enroll, please try to select the location that is most convenient for you to reduce travel requirements."

Answered by AI

Who else is applying?

What site did they apply to?
Shultz Vision
SightMD
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I am uncomfortable in the winter months with dry eye syndrome.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512
2022. "A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05493111.
~114 spots leftby Apr 2025
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