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Systane® Hydration PF and Systane® Hydration Preserved

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05932238
Collaborator
(none)
135
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
16.9
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 Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.

Condition or Disease Intervention/Treatment Phase
  • Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)
  • Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved
 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 :
135 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systane® Hydration PF and Systane® Hydration Preserved
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Systane Hydration Preservative Free (PF)

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

Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)
commercially available eye drops
Other Names:
  • Systane Hydration Preservative Free (PF)

    		•
    Experimental: Systane Hydration Preserved

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

    Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved
    commercially available eye drops
    Other Names:
  • Systane Hydration Preserved

    		•

    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 and Group 3 [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:
    No
    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:
    NCT05932238
    Other Study ID Numbers:
    • DEN923-I001
    First Posted:
    Jul 6, 2023
    Last Update Posted:
    Jul 7, 2023
    Last Verified:
    Jul 1, 2023
    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
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Jul 7, 2023