N/A
N=144
Product Feasibility of a New Silicone Hydrogel Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01309100 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Visual Acuity (Investigational vs Air Optix Aqua Lens) — -0.050; -0.060; -0.034; -0.039 LogMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Lens (Device); Acuvue Oasys Lens (Device); Air Optix Aqua Lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (Investigational vs Air Optix Aqua Lens) |
-0.050; -0.060; -0.034; -0.039 | — |
| PRIMARY Visual Acuity (Investigational vs Acuvue Oasys Lens) |
-0.050; -0.048; -0.034; -0.033 | — |
| SECONDARY Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens) |
80.9; 86.5 | — |
| SECONDARY Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens) |
80.9; 82.1 | — |
Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.
Eligibility Criteria
Inclusion Criteria
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Subjects must be myopic and require lens correction
Exclusion Criteria
- Subjects with any systemic disease affecting ocular health.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects with an active ocular disease or are using any ocular medication.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
Data sourced from ClinicalTrials.gov (NCT01309100). 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.