Status:
COMPLETED
Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborating Sponsors:
Johnson & Johnson K.K. Medical Company
Visioncare Research Ltd.
Conditions:
Myopia
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.
Eligibility Criteria
Inclusion
- At least 18 years of age and no more than 39 years of age
- Existing soft contact lens wearers
- Willing to signed a written Informed Consent.
- Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
- Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
- Have an Astigmatism of 1.00D or less in both eyes.
- Require a visual correction in both eyes.
- Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
- Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.
Exclusion
- Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Clinically significant corneal staining (Grade 3 in more than one region).
- Keratoconus or other corneal irregularity.
- Abnormal lachrymal secretions.
- Extended wear of contact lenses last 3 months.
- Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
- Refractive surgery.
- Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Require concurrent ocular medication
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
- Diabetes.
- Pregnant, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial or in last 30 days.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01155323
Start Date
March 1 2010
End Date
June 1 2010
Last Update
June 19 2018
Active Locations (1)
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1
Singapore Plytechnic
Singapore, Singapore, 139651