Systane® Complete Preservative Free Lubricant Eye Drops

Last updated: March 19, 2025
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Propylene glycol solution/drops

Clinical Study ID

NCT05932225
DEC262-I001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject must be able to understand and sign an informed consent form

  • Subject with mild to moderate dry eye

  • Other protocol-defined inclusion criteria may apply

Exclusion

Exclusion Criteria:

  • Has suffered any ocular injury to either eye in the past 3 months prior toscreening.

  • Has undergone any other ocular surgery (including intraocular surgery) within thepast 6 months or has any ocular surgery planned during the study.

  • Other protocol-defined exclusion criteria may apply

Study Design

Total Participants: 71
Treatment Group(s): 1
Primary Treatment: Propylene glycol solution/drops
Phase:
Study Start date:
August 18, 2023
Estimated Completion Date:
February 20, 2024

Study Description

Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete the Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.

Connect with a study center

  • Integra Eye Care

    Burnaby, British Columbia V5E 1G3
    Canada

    Site Not Available

  • Aggarwal and Associates Limited

    Brampton, Ontario L6T 0G1
    Canada

    Site Not Available

  • Eyes on Sheppard Clinic

    North York, Ontario M2N 3A1
    Canada

    Site Not Available

  • University of Waterloo Centre for Contact Lens Research

    Waterloo, Ontario N2L 3G1
    Canada

    Site Not Available

  • Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

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