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 range18 Years

SexALL

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.

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)

Mean Change From Baseline in Hematology by Visit - Basophil Level

Timeframe: Baseline (Day 1 pretreatment), Day 180, Day 365

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 range18 Years

SexALL

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)

Mean Change From Baseline in Hematology by Visit - Basophil Level

Timeframe: Baseline (Day 1 pretreatment), Day 180, Day 365