Status:
COMPLETED
Clinical Comparison of Two Silicone-Hydrogel Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborating Sponsors:
Foresight Regulatory Strategies, Inc.
Visioncare Research Ltd.
Conditions:
Refractive Error
Eligibility:
All Genders
18-39 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.
Eligibility Criteria
Inclusion
- The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
- The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
- The subject, based on his/her knowledge, must be in good general health.
- The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
- Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
- Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
- Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
- The subject must read, indicate understanding of and sign the Informed Consent Form.
Exclusion
- The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
- The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
- The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
- Slit lamp findings that would contraindicate contact lens wear such as:
- pathological dry eye or associated findings
- pterygium or corneal scars within the visual axis
- neovascularization equal to or greater than 1mm in from the limbus
- history of giant papillary conjunctivitis (GPC) worse than grade 2
- anterior uveitis or iritis (past or present)
- seborrhoeic eczema
- seborrhoeic conjunctivitis
- A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
- A known history of corneal hypoesthesia (reduced corneal sensitivity).
- Contact lens snellen visual acuities (VA) worse than 20/30.
- Aphakia, keratoconus or a highly irregular cornea.
- Current pregnancy or lactation (to the best of the subject's knowledge)
- Any active participation in another clinical study at any time during this study.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00762385
Start Date
August 1 2007
End Date
October 1 2007
Last Update
June 19 2018
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