Status:
COMPLETED
Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.
Eligibility Criteria
Inclusion
- Be of legal age (i.e. 18 years)
- Be of Asian descent and have -Asian eye‖ identifying features (see Appendix A)
- Be mentally competent, willing and able to sign a written informed consent form.
- Have contact lens distance sphere requirement in the range 1.00D to 6.00D.
- Have spectacle astigmatism \<1.25D in each eye
- Currently wear soft contact lenses (for at least 3 months prior to the trial ) without experiencing difficulties or contact lens related complications
- Have had an oculo-visual examination within the previous 12 months.
- 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 evidence of lid abnormality or infection
- No conjunctival abnormality or infection
- No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
- No other active ocular disease
Exclusion
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal staining (FDA scale), corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Has had refractive surgery.
- Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrolment for this study.
- History of abnormal lachrymal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Extended lens wear in last 3 months.
- PMMA, hybrid or RGP 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.
- Has diabetes
- Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- History of chronic eye disease (e.g. glaucoma or ARMD).
- Pregnancy, lactating, or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
- Family member or employee of the clinical site, investigator or other study staff.
- Currently wears habitual contact lenses on an EW basis.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01482819
Start Date
October 1 2011
End Date
December 1 2011
Last Update
June 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hawthorn, Victoria, Australia, 3122