Clinical Trial of Several Contact Lenses in Extended Wear
NCT ID: NCT00762788
Last Updated: 2015-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2007-02-28
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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senofilcon A contact lens
ACUVUE OASYS
senofilcon A
1 week extended wear contact lens
lotrafilcon A contact lens
NIGHT\&DAY
lotrafilcon A
1 week extended wear contact lens
lotrafilcon B contact lens
O2Optix
lotrafilcon B
1 week extended wear contact lens
balafilcon A contact lens
PureVision
balafilcon A
1 week extended wear contact lens
comfilcon A contact lens
Biofinity
comfilcon A
1 week extended wear contact lens
etafilcon A contact lens
ACUVUE 2
etafilcon A
1 week extended wear contact lens
Interventions
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senofilcon A
1 week extended wear contact lens
lotrafilcon A
1 week extended wear contact lens
lotrafilcon B
1 week extended wear contact lens
balafilcon A
1 week extended wear contact lens
comfilcon A
1 week extended wear contact lens
etafilcon A
1 week extended wear contact lens
Eligibility Criteria
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Inclusion Criteria
* Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
* Require a visual correction in both eyes (Monovision not allowed)
* Require a soft contact lens spherical correction between -0.50 and -9.00D.
* Have an astigmatic correction less than 1.50D in both eyes.
* Be able to wear the lens powers available for this study.
* Be able to regularly wear the lenses on a 7 day/6 night extended wear basis (e.g. does not regularly swim more than once a week)
* Be correctable to a visual acuity of 20/30 or better in each eye.
* 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 amblyopia.
* No evidence of lid abnormality or infection.
* No clinically significant slit lamp findings
* No other active ocular disease.
* No previous ocular surgery.
Exclusion Criteria
* Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* No Clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Diabetic.
* Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* PMMA or RGP lens wear in the previous 8 weeks.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment only.
* Participation in any concurrent clinical trial.
* Currently wearing B\&L PureVision, Ciba O2 Optix, Ciba Night \& Day, CooperVision Biofinity, Vistakon ACUVUE® OASYS, or Vistakon ACUVUE®2 on an EW basis
* Has had previous adverse event(s) contraindicating EW e.g. MK or greater than 2 corneal scars which appear to be contact lens related (e.g. not trauma related).
* Has had an eye injury or surgery within the last eight weeks.
18 Years
39 Years
ALL
No
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Locations
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Vision Research Foundation
Chennai, Tamil Nadu, India
Countries
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Other Identifiers
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CR-4472
Identifier Type: -
Identifier Source: org_study_id
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