A Study to Investigate the Effect of 0.003% AR-15512 on Subjects With Dry Eye Disease

Last updated: March 21, 2025
Sponsor: Alcon Research
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Sjogren's Syndrome

Dry Eyes

Treatment

Artificial Tears

0.003% AR-15512

Clinical Study ID

NCT06544694
DEF512-E003
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Have a previous history of DED, clinician diagnosed or patient reported, within theprevious 6 months prior to the Screening visit.

  • Have used artificial tears for DED symptoms within 2 months prior to the Screeningvisit.

  • Corrected visual acuity equal to or better than logarithm Minimum angle ofreflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), asassessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyesat both the Screening and Baseline visits.

  • Good general and ocular health, as determined by the investigator using medicalhistory, ophthalmic examination and history.

  • Other protocol specified inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • History or presence of any ocular disorder or condition (other than DED) in eithereye that would, in the opinion of the investigator, interfere with theinterpretation of the study results or subject safety.

  • Current evidence of other significant ophthalmic disease requiring topicalmedication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease whichthe investigator believes may interfere with study findings or interpretation.

  • History of ocular surgery within 1 year prior to the Screening visit; history ofcorneal transplant in one or both eyes.

  • Use of contact lenses in either eye within 7 days prior to the Screening visit orplanned use during the study.

  • Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14days prior to the Screening visit or any planned use during the study.

  • Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study.

  • Other protocol-specified exclusion criteria may apply.

Study Design

Total Participants: 79
Treatment Group(s): 2
Primary Treatment: Artificial Tears
Phase: 3
Study Start date:
October 08, 2024
Estimated Completion Date:
March 21, 2025

Study Description

Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily.

This is a Phase 3b study.

Connect with a study center

  • Oculus Research

    Garner, North Carolina 27529
    United States

    Site Not Available

  • Wilmington Eye

    Leland, North Carolina 28451
    United States

    Site Not Available

  • CORE, Inc.

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Contact Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

  • Butchertown Clinical Trials

    Houston, Texas 77030
    United States

    Site Not Available

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