NCT05902364

Systane® Ultra Preservative Free Lubricant Eye Drops

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Dry Eye

Interventions

Type	Name	Description
OTHER	Systane Ultra PF lubricant eye drops	Commercially available preservative free eye drops

Timeline

• Start date: 2023-10-28
• Primary completion: 2024-08-14
• Completion: 2024-08-14
• First posted: 2023-06-15
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

4 sites across 2 countries: Canada, New Zealand