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Systane® Hydration PF and Systane® Hydration Preserved

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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)

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

Trial contacts and locations

3

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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