Status:
COMPLETED
A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs (HOP/SiH) and A Control, Standard O2 Lens
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
CIBA VISION
National Eye Institute (NEI)
Conditions:
Contact Lenses, Extended-Wear
Eligibility:
All Genders
18-38 years
Phase:
NA
Brief Summary
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses by study...
Detailed Description
The purpose of this research is to compare the on-eye performance of 12 month daily wear versus 6-night extended wear and 30-night extended wear of novel hyper-oxygen permeable contact lenses on bacte...
Eligibility Criteria
Inclusion
- The age requirement for this study is between 18-38 years old. The subject has to have nearsightedness in between -1.00D and -6.00D with regular astigmatism of an amount in both eyes that will not necessitate the need for toric lenses. No prior history of any lens wear within one month of entry into the contact lens phase of the study. Visual acuity of 20/30 or better during test lens wear. Normal anatomy and physiology of the eye. No eye cosmetic use on the day of study visits. Normal appearance of the cornea with slit lamp examination, stable tear film and sufficient tear production. Intraocular pressure less than or equal to 21 mmHg by Goldmann applanation. Absence of any intraocular inflammation. Normal appearance of optic nerve, macula and peripheral retina by direct fundus examination.
Exclusion
- Patients with chronic ocular conditions are excluded from the study (i.e. dry eye, recurrent corneal epithelial erosion). History of allergic eye disease either seasonal or associated with previous contact lens wear. Use of any topically applied ocular medication or systemic medication specifically including but not limited to, antihistamines, aspirin-related drugs, or psychoactive or anti-depressant medication. Oral contraceptives are allowed. Currently suspected or actual pregnancy. Study terminates if pregnancy occurs. Patients will not be enrolled if they are currently in another ophthalmic research project.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00344643
Start Date
October 1 2004
End Date
December 1 2006
Last Update
June 23 2008
Active Locations (1)
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1
University of Texas Southwestern Medical Center At Dallas
Dallas, Texas, United States, 75390