N/A
Completed N=166
A Study to Evaluate the Safety and Efficacy of a New Silicone Hydrogel Contact Lens Design
Source: ClinicalTrials.gov NCT01449526 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Visual Acuity (VA) — -0.033; -0.038 LogMAR
Summary
The objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the Bausch + Lomb PureVision contact lens when worn by adapted soft contact lens wearers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity (VA) |
-0.033; -0.038 | — |
| SECONDARY Slit Lamp > Grade 2 |
2; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be myopic, and wear contact lenses in each eye.
- Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months.
Exclusion Criteria
- Subjects who are older than age 40 on the date the informed consent (ICF) is signed.
- 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 an active ocular disease or who are using any ocular medication.
- Subjects with any grade 2 or greater finding during the slit lamp examination.
- Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Subjects who are allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01449526). 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. Informational only — not medical advice.