Clincosm LogoSign in Get a demo

Systane® Ultra Preservative Free Lubricant Eye Drops

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05902364
Collaborator
(none)
68
Enrollment
1
Location
1
Arm
2
Anticipated Duration (Months)
33.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Statistical analyses will be presented by group.

Condition or Disease Intervention/Treatment Phase
  • Other: Polyethylene glycol 400 and propylene glycol solution/drops
 N/A

Detailed Description

Subjects will participate in the study for approximately 30 days, with 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 patient questionnaires on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB] or Contact Lens Dry Eye Questionnaire [CLDEQ-8] and Comfortable Wear Time questions).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systane® Ultra Preservative Free Lubricant Eye Drops
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Systane Ultra Preservative-Free

1-2 drops in each eye four times a day for 30 days

Other: Polyethylene glycol 400 and propylene glycol solution/drops
commercially available eye drops
Other Names:
  • Systane Ultra Preservative-Free

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean overall IDEEL-Symptom Bother(SB) score - Group 1 [Visit 3 (Day 30)]

      The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint.

    2. Resultant overall CLDEQ-8 score - Group 2 [Visit 3 (Day 30)]

      The CLDEQ-8 is an eight-item questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. Each question is answered using a 0-4, 0-5, or 1-6 Likert scale for a resultant overall score of 1-37. No statistical hypothesis is pre-specified for this endpoint.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

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

    • Subject with mild to moderate dry eye

    • Subject with CL-related dry eye symptoms

    • Other protocol-defined inclusion criteria may apply

    Exclusion Criteria:

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

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

    • Other protocol-defined exclusion criteria may apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alcon Call Center for Trial Locations Fort Worth Texas United States 76134

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Lead, Vision Care, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05902364
    Other Study ID Numbers:
    • DEU894-I001
    First Posted:
    Jun 15, 2023
    Last Update Posted:
    Jun 15, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes

    Study Results

    No Results Posted as of Jun 15, 2023