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

NCT05493111 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-08-13

Study results available
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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.

Conditions

Interventions

DRUG

0.003% AR-15512 ophthalmic solution

Active ingredients administered via topical ocular instillation

DRUG

AR-15512 vehicle ophthalmic solution

Inactive ingredients administered via topical ocular instillation

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Scientific Advisor, CRD · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-02-28
Completion
2024-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05493111 on ClinicalTrials.gov