Systane® Hydration PF and Systane® Hydration Preserved

Dry Eye Clinical Trial

Official title:

Systane® Hydration PF and Systane® Hydration Preserved

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932238
• Other study ID #: DEN923-I001
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• 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 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.

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: 135
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• 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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Intervention

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

Locations

Country	Name	City	State
Canada	Aggarwal and Associates Limited	Brampton	Ontario
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 and Group 3	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)