Status:
COMPLETED
Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.
Eligibility Criteria
Inclusion
- Be no less than 18 and no more than 39 years of age.
- Sign Written Informed Consent and investigator to record this on Case Report Form.
- Be willing and able to adhere to the instructions set out in the protocol.
- Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
- No extended wear in the last 3 months.
- Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
- Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
- Achieve visual acuity of 6/9 (20/30) or better in each eye.
- Require a visual correction in both eyes (no monovision allowed).
- 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 (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.
Exclusion
- Requires concurrent ocular medication.
- Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Clinically significant corneal staining
- Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
- 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.
- Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease \[e.g., Human immunodeficiency virus (HIV)\].
- History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
- Pregnancy, 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 :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT01244516
Start Date
September 1 2010
End Date
November 1 2010
Last Update
June 19 2018
Active Locations (35)
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1
Brea, California, United States, 92891
2
Campbell, California, United States, 95008
3
Cupertino, California, United States, 95014
4
Mission Viejo, California, United States, 92691