N/A
N=118
Feasibility of a New Silicone Hydrogel Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01131130 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens — 74.3; 79.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational contact lens (Device); Acuvue Oasys Contact Lens (Device); Air Optix Aqua (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens |
74.3; 79.4 | — |
| PRIMARY Comfort Throughout the Day - Test Lens vs. Acuvue Oasys |
74.3; 88.0 | — |
| SECONDARY Lens Wettability, Test Lens vs. Acuvue Oasys |
210; 214; 14; 16; 1; 0 | — |
| SECONDARY Lens Wettability, Test Lens vs. Air Optix Aqua |
210; 219; 14; 10; 1; 0 | — |
Summary
The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.
Eligibility Criteria
Inclusion Criteria
- Participants must have clear central corneas and be free of any anterior segment disorders.
- Participants 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.
- Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.
Exclusion Criteria
- Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Participants with any systemic disease affecting ocular health.
- Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Participants with an active ocular disease or are using any ocular medication.
- Participants who have had any corneal surgery (eg, refractive surgery).
- Participants who are allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01131130). 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.