NCT05932225

Systane® Complete Preservative Free Lubricant Eye Drops

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (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 Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group.

Detailed description

Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, 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 the Impact of Dry Eye on Everyday Life - Symptom Bother \[IDEEL-SB\]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.

Conditions

• Dry Eye

Interventions

Type	Name	Description
OTHER	Propylene glycol solution/drops	Commercially available eye drops

Timeline

• Start date: 2023-08-18
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2023-07-06
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

4 sites across 1 country: Canada