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

NCT04498182 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2024-08-28

Study results available
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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.

Conditions

Interventions

DRUG

AR-15512 Ophthalmic Solution

Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)

DRUG

AR-15512 Ophthalmic Solution Vehicle

Ophthalmic solution vehicle administered via topical ocular instillation

Sponsors & Collaborators

  • Aerie Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Scientific Advisor, Clinical Research and Development · Alcon Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2021-07-17
Completion
2021-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04498182 on ClinicalTrials.gov