N/A
N=66
Evaluation of the Feasibility a New Silicone Hydrogel Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01309906 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Visual Acuity — -0.038; -0.040 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational lens (Device); Air Optix Aqua lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.038; -0.040 | — |
| SECONDARY Percentage of Eyes With > Grade 2 Slit Lamp Findings |
0; 0 | — |
| SECONDARY Symptoms and Complaints |
89.7; 90.5; 86.6; 86.9; 85.7; 87.8 | — |
Summary
The objective of this study is to determine the clinical feasibility and to evaluate the product performance of an investigational contact lens.
Eligibility Criteria
Inclusion Criteria
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Be myopic and require lens correction in each eye.
- Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion Criteria
- Any systemic disease affecting ocular health.
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- An active ocular disease, any corneal infiltrative response or are using any ocular medications.
- Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01309906). 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.