2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Normalized logMAR Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Samfilcon A Lenses with EPG01 Packaging Solution
Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution
Intervention: samfilcon A Lenses with EPG01 Packaging Solution (Device)
Commercially Available B+L Ultra Lenses
Subjects implanted with Commercially Available B+L Ultra Lenses
Intervention: Commercially Available B+L Ultra Lenses (Device)
Outcomes
Primary Outcomes
Normalized logMAR Visual Acuity
Time Frame: 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 Outcomes
No secondary outcomes reported