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

Phase 3

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: 0.003% AR-15512 ophthalmic solution; Drug: REFRESH® Classic ophthalmic solution

• Registration Number: NCT06660290
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Study Start: 2025-01-15
• Status Verified: 2025-02
• Primary Completion: 2025-02-06
• Study Completion: 2025-02-06
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
REFRESH® Classic, then 0.003% AR-15512	0.003% AR-15512 ophthalmic solution	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
REFRESH® Classic, then 0.003% AR-15512	REFRESH® Classic ophthalmic solution	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

Primary Outcome Measures

Name	Time	Method
Percentage of Ocular Adverse Events	Day 1 post drop instillation	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.

Trial Locations

Locations (6)

Advancing Vision Research, LLC; 🇺🇸 Smyrna, Tennessee, United States

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

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States