N/A
N=265
Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers
Vision Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00985231 ↗Enrolled (actual)
265
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. — 2; 0 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PureVision Multi-Focal contact lenses (Device); SofLens59 contact lens (Device)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40. |
2; 0 | — |
| SECONDARY Subjective Ratings of Eye Strain |
9.9; 9.0 | — |
Summary
This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.
Eligibility Criteria
Inclusion Criteria
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.
- Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.
Exclusion Criteria
- Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
- Subjects with any systemic disease affecting ocular health
- Subjects with an active ocular disease or using any ocular medication.
- Subjects who have had any corneal surgery (eg, refractive surgery).
Data sourced from ClinicalTrials.gov (NCT00985231). 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.