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N/A N=41 Randomized Double-blind Other

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

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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