A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease

Summary

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.

Timeline

Start

2020-10-26

Primary completion

2021-07-17

Completion

2021-07-17

Outcome

Missed primary endpoint

registry analysis (superiority test); AR-15512 Ophthalmic Solution Higher Dose vs Vehicle; p = 0.2305; LS Mean Difference -3.4 (95% CI -8.9 to 2.2); ANCOVA NCT04498182 ↗

registry analysis (superiority test); AR-15512 Ophthalmic Solution Lower Dose vs Vehicle; p = 0.7436; LS Mean Difference 0.9 (95% CI -4.6 to 6.4); ANCOVA NCT04498182 ↗

registry analysis (superiority test); AR-15512 Ophthalmic Solution Higher Dose vs Vehicle; p = 0.4936; LS Mean Difference -0.5 (95% CI -1.9 to 0.9); ANCOVA NCT04498182 ↗

registry analysis (superiority test); AR-15512 Ophthalmic Solution Lower Dose vs Vehicle; p = 0.7131; LS Mean Difference 0.3 (95% CI -1.1 to 1.6); ANCOVA NCT04498182 ↗

Publications

• Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acoltremon	Small molecule	0.0014 %	Topical
Subject	Acoltremon	Small molecule	0.003 %	Topical

Indications