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

Last updated: February 11, 2025
Sponsor: Alcon Research
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Treatment

0.003% AR-15512 ophthalmic solution

REFRESH® Classic ophthalmic solution

Clinical Study ID

NCT06660290
DEF512-E005
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 medicalhistory, ophthalmic examination and history;

  • Capable of giving signed informed consent.

Exclusion

Key Exclusion Criteria:

  • Current evidence of other clinically significant ophthalmic disease other than dryeye;

  • 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 30days of the Study Visit;

  • Positive pregnancy test or currently breastfeeding.

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: 0.003% AR-15512 ophthalmic solution
Phase: 3
Study Start date:
January 15, 2025
Estimated Completion Date:
February 06, 2025

Study Description

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

Connect with a study center

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Vision Institute

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Advancing Vision Research, LLC

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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