Systane® Hydration PF and Systane® Hydration Preserved

Alcon

Status: Active, not recruiting

Conditions: Dry Eye

Treatments: Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF); Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved

Study type: Interventional

Funder types: Industry

Identifiers

NCT05932238

DEN923-I001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Systane Hydration Preservative Free (PF)

Experimental group

Description:

1-2 drops in each eye four times a day for 30 days

Treatment:

Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)

Systane Hydration Preserved

Experimental group

Description:

1-2 drops in each eye four times a day for 30 days

Treatment:

Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved