N/A
N=41
Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01244529 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Lens Centration Acceptance — 74; 62; 69; 8 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- galy A Plus (Device); seno A (Device); galy A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Centration Acceptance |
74; 62; 69; 8; 20; 13 | — |
| PRIMARY Primary Gaze Lens Movement |
93; 93; 100; 93; 90; 98 | — |
| PRIMARY Fit Acceptability |
90; 90; 95; 83; 71; 80 | — |
| SECONDARY New Lens Power Fit Match to Control Lenses |
98; 98; 98; 98; 2; 2 | — |
Summary
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
Eligibility Criteria
Inclusion Criteria
- Must be at least 18 years of age and no more than 55 years of age.
- Must sign written informed consent.
- Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
- Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
- Must have visual acuity best correctable to 20/25+3 or better for each eye.
- Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
- The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
Exclusion Criteria
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Any previous eye surgery involving the anterior segment.
- Pre-existing ocular disease that would preclude contact lens fitting.
- Abnormal lacrimal secretions.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial.
- Subject's habitual contact lens type is toric or multifocal.
- Require any concurrent ocular medication.
Data sourced from ClinicalTrials.gov (NCT01244529). 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.