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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-02-06

Brief Summary

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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.

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Detailed Description

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

Conditions

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Dry Eye Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

In this single arm study, the subject is masked as to when they receive the Refresh Classic.

Study Groups

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REFRESH® Classic, then 0.003% AR-15512

One drop of REFRESH® Classic ophthalmic solution administered topically to the eye, followed by 0.003% AR-15512 ophthalmic solution administered topically to the eye

Group Type EXPERIMENTAL

0.003% AR-15512 ophthalmic solution

Intervention Type DRUG

Investigational ophthalmic solution for topical instillation

REFRESH® Classic ophthalmic solution

Intervention Type DRUG

Commercially available ophthalmic solution for topical instillation

Interventions

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0.003% AR-15512 ophthalmic solution

Investigational ophthalmic solution for topical instillation

Intervention Type DRUG

REFRESH® Classic ophthalmic solution

Commercially available ophthalmic solution for topical instillation

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No