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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05902364
Other study ID # DEU894-I001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 28, 2023
Est. completion date July 2024

Study information

Verified date January 2024
Source Alcon Research
Contact Alcon Call Center
Phone 1-888-451-3937
Email alcon.medinfo@alcon.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. This study will be conducted in Canada, Australia, and New Zealand.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Polyethylene glycol 400 and propylene glycol solution/drops
commercially available eye drops

Locations

Country Name City State
Canada Integra Eye Care Burnaby British Columbia
Canada University of Waterloo School of Optometry Waterloo Ontario

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean overall IDEEL-Symptom Bother(SB) score - Group 1 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. Visit 3 (Day 30)
Primary Resultant overall CLDEQ-8 score - Group 2 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. Visit 3 (Day 30)
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