Status:
COMPLETED
Clinical Evaluation of Two Daily Disposable Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborating Sponsors:
Singapore Polytechnic University
Visioncare Research Ltd.
Conditions:
Refractive Error
Eligibility:
All Genders
21-39 years
Phase:
NA
Brief Summary
This study seeks to evaluate the clinical performance of two daily disposable contact lenses.
Eligibility Criteria
Inclusion
- Be between 21 and 39 years of age.
- Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.
- Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
- Require a visual correction in both eyes (monovision allowed but no monofit).
- Have a contact lens spherical distance requirement between -1.00D and -6.00D in both eyes.
- Astigmatism of 1.00D or less in both eyes.
- Be able to wear the lens powers available for this study.
- 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 conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).
- No other active ocular disease.
Exclusion
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularisation, 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).
- Extended lens wear in last 3 months.
- 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 enrollment 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.
- Participation in any concurrent clinical trial or in last 60 days."
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01163760
Start Date
September 1 2007
End Date
September 1 2007
Last Update
June 19 2018
Active Locations (1)
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1
Singapore, Singapore