N/A
N=33
Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses
Contact Lens Wearer
Bottom Line
View on ClinicalTrials.gov: NCT05129488 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Normalized logMAR Visual Acuity — -0.01; -0.02 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- All participants received Biotrue ONEday lenses with and without an alternate packaging solution (EPG03) (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 |
-0.01; -0.02 | — |
Summary
The objective of this 2 hour study is to evaluate the clinical performance of Biotrue ONEday lenses with an alternate packaging solution (EPG03) compared to commercially available Biotrue ONEday lenses. This novel contact lens packaging solution contains known elements in the ophthalmic industry and is safe for use.
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 (NCT05129488). 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.