N/A
N=173
Safety and Efficacy of a Contact Lens for Daily Disposable Use
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01365039 ↗Enrolled (actual)
173
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Slit Lamp Findings > Grade 2 — 0; 1 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test, daily disposable contact lens (Device); SofLens daily disposable contact lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slit Lamp Findings > Grade 2 |
0; 1 | — |
| PRIMARY High Contrast, Distance logMAR Visual Acuity (VA) |
-0.028; -0.025 | — |
Summary
This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
Eligibility Criteria
Inclusion Criteria
- Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
- Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
- Subjects must be free of any anterior segment disorders.
- Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.
Exclusion Criteria
- Subjects 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.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Subjects who have had any corneal surgery (eg, refractive surgery).
- Subjects who are allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01365039). 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.