N/A
N=30
2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses
Contact Lens Wearer
Bottom Line
View on ClinicalTrials.gov: NCT05126953 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Normalized logMAR Visual Acuity — 0.005; 0.003; -0.001; 0.008 LogMAR units
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- samfilcon A Lenses with EPG01 Packaging Solution (Device); Commercially Available B+L Ultra Lenses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalized logMAR Visual Acuity |
0.005; 0.003; -0.001; 0.008 | — |
Summary
The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
- Have signed a statement of informed consent.
Exclusion Criteria
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation.
Data sourced from ClinicalTrials.gov (NCT05126953). 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.