Phase 3 N=467 Randomized Double-blind Treatment

Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)

Dry Eye Disease

Bottom Line

View on ClinicalTrials.gov: NCT05360966 ↗

Enrolled (actual)

467

Serious AEs

0.6%

Results posted

Jul 2025

Primary outcome: Primary: Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score — 53.2; 14.4 percentage of subjects — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 0.003% AR-15512 ophthalmic solution (Drug); AR-15512 vehicle ophthalmic solution (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Aerie Pharmaceuticals
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score	53.2; 14.4	<0.0001 sig
SECONDARY Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28	-22.3; -19.1	0.1321
SECONDARY Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)	10.9; 2.6	<0.0001 sig
SECONDARY Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score	53.7; 13.7	<0.0001 sig
SECONDARY Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)	10.9; 3.3	<0.0001 sig
SECONDARY Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score	59.2; 21.9	<0.0001 sig
SECONDARY Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)	11.7; 3.7	<0.0001 sig
SECONDARY Least Squares Mean Change From Baseline in Global SANDE Score on Day 90	-28.3; -26.9	0.5626
SECONDARY Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90	-28.6; -27.2	0.5981
SECONDARY Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90	-27.0; -25.4	0.5161
SECONDARY Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90	-22.4; -22.8	0.8574
SECONDARY Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90	-35.0; -34.0	0.6980

Summary

This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.

Eligibility Criteria

Key Inclusion Criteria

Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;
Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;
Other protocol-specified inclusion criteria may apply.

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;
Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;
Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;
Medication use as specified in the protocol;
History or presence of significant systemic disease;
Other protocol-specified exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05360966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.