NCT05932238

Systane® Hydration PF and Systane® Hydration Preserved

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Timeline

• Start date: 2023-10-06
• Primary completion: 2024-09-05
• Completion: 2024-09-05
• First posted: 2023-07-06
• Last updated: 2024-09-19

Locations

3 sites across 1 country: Canada