N/A
N=816
Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT02939950 ↗Enrolled (actual)
816
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: High Contrast Visual Acuity — -0.065; -0.047 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bausch + Lomb Samfilcon A Soft Contact Lens (Device); Bausch + Lomb Pure Vision Soft Contact Lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY High Contrast Visual Acuity |
-0.065; -0.047 | — |
| PRIMARY Number of Participants With Adverse Events |
22; 14 | — |
Summary
The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.
Eligibility Criteria
Inclusion Criteria
- Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
- Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
- Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.
Exclusion Criteria
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with an active ocular disease or who are using any ocular medication.
- Participants with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
- Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
- Participants who currently wear monovision, multifocal, or toric contact lenses.
Data sourced from ClinicalTrials.gov (NCT02939950). 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.