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A clinical trial to evaluate etafilcon A contact lenses worn in an extended wear mode (7 days and 6 nights of extended wear)

Phase 4
Completed
Conditions
Health Condition 1: null- Vision Correction
Registration Number
CTRI/2011/06/001848
Lead Sponsor
Johnson and Johnson Vision Care Inc
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

A.Be between 18 and 39 years of age.

B.Require a visual correction in both eyes (Monovision not allowed)

C.Require a soft contact lens spherical correction between -0.50 and -5.75D in both eyes.

D.Have an astigmatic correction less than 1.50D in both eyes.

E.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)

F.Be correctable to a visual acuity of 20/30 or better in each eye with spherical distance correction.

G.Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria

A.Requires concurrent ocular medication.

B.Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.

C.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.

D.Is currently or has previously worn any hard PMMA or RGP contact lenses.

Study & Design

Study Type
PMS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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