N/A
Completed N=68
Systane® Ultra Preservative Free Lubricant Eye Drops
Source: ClinicalTrials.gov NCT05902364 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Mean Overall IDEEL SB Score - Group 1 — 45.53; 31.23 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overall IDEEL SB Score - Group 1 |
45.53; 31.23 | — |
| PRIMARY Mean Overall CLDEQ-8 Score - Group 2 |
19.4; 10.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must be able to understand and sign an informed consent form.
- Subject with mild to moderate dry eye.
- Subject with contact lens-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.
Data sourced from ClinicalTrials.gov (NCT05902364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.