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

Alcon

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: 0.003% AR-15512 ophthalmic solution; Drug: REFRESH® Classic ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT06660290

DEF512-E005

Details and patient eligibility

About

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.

Full description

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

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

REFRESH® Classic, then 0.003% AR-15512

Experimental group

Description:

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

Treatment:

Drug: REFRESH® Classic ophthalmic solution

Drug: 0.003% AR-15512 ophthalmic solution