CompletedPhase 3

A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512

United States275 participantsStarted 2022-11-01

Plain-language summary

The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit. * Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit. * Corrected visual acuity as specified in the protocol at the Baseline visit. * Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit. Key Exclusion Criteria: * History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety. * Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation. * Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study. * Use of medications as specified in the protocol. * Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent

Timeframe: Day 1 post-treatment, up to Day 365

Mean Change From Baseline in Heart Rate at Each Study Visit

Timeframe: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit

Timeframe: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit

Timeframe: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365

Timeframe: Baseline (Day 1 pretreatment), Day 365

Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit

Timeframe: Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit)

Trial details

NCT IDNCT05493111

SponsorAerie Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-28

Results submitted2025-06-02

View on ClinicalTrials.gov More Dry Eye Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent

Timeframe: Day 1 post-treatment, up to Day 365

Mean Change From Baseline in Heart Rate at Each Study Visit

Timeframe: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit

Timeframe: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit

Timeframe: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365

Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365

Timeframe: Baseline (Day 1 pretreatment), Day 365

Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit

Timeframe: Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit)