A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes

Alcon Research55 enrolled

Overview

The purpose of this study is to evaluate the proportion of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and Refresh® Classic.

This is a 1-visit study (Screening, Enrollment, Assessments).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Disease

Interventions

0.003% AR-15512 ophthalmic solutionDRUG

Investigational ophthalmic solution for topical instillation

REFRESH® Classic ophthalmic solutionDRUG

Commercially available ophthalmic solution for topical instillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Corrected Visual Acuity (Snellen) 20/200 or better in both eyes; * Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history; * Capable of giving signed informed consent. Key Exclusion Criteria: * Current evidence of other clinically significant ophthalmic disease other than dry eye; * History of ocular surgery within 1 year of the Study Visit; * Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit; * Positive pregnancy test or currently breastfeeding.

Locations (6)

Eye Research Foundation

Newport Beach, California, United States

Vision Institute

Colorado Springs, Colorado, United States

Andover Eye Associates

Andover, Massachusetts, United States

Total Eye Care, PA

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Percentage of Ocular Adverse Events

Adverse Events are defined as any untoward medical occurrences associated with the administration of the study intervention in humans, whether or not considered to be related to the study intervention.

Time frame: Day 1 post drop instillation

Data from ClinicalTrials.gov

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