N/A
Completed N=68
Systane® Complete Preservative Free Lubricant Eye Drops
Source: ClinicalTrials.gov NCT05932225 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group — 41.36; 47.08; 47.63; 31.26 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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group |
41.36; 47.08; 47.63; 31.26; 32.16; 32.91 | — |
| PRIMARY Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects |
46.08; 32.24 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must be able to understand and sign an informed consent form
- Subject with mild to moderate dry eye
- 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 (NCT05932225). 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.