2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses
Not Applicable
Completed
- Conditions
- Contact Lens Wearer
- Registration Number
- NCT05126953
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Normalized logMAR Visual Acuity Assessed at 2-hour post-baseline Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bausch and Lomb Site 01
🇺🇸Rochester, New York, United States
Bausch and Lomb Site 01🇺🇸Rochester, New York, United States