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A Comparison of 12 Month Daily Wear of Two Novel O2 Permeable Silicone Hydrogel CLs (HOP/SiH) and A Control, Standard O2 Lens

This study has been completed.
Sponsor:
Collaborators:
CIBA VISION
National Eye Institute (NEI)
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00344643
First received: June 23, 2006
Last updated: June 19, 2008
Last verified: June 2008
History of Changes
  Purpose

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 studying its effects on human eyes. Usual and customary care will be given in the form of eyeglasses and/or contact lenses.


Condition Intervention
Contact Lenses, Extended-Wear
 Device: Silicone Hydrogel Soft Contact Lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Comparison of 12 Month Daily Wear of Two Novel Hyper-Oxygen Permeable Silicone Hydrogel Contact Lenses (HOP/SiH) and A Control, Standard Oxygen Permeable Lens; and, 30-Night Versus 6-Night Immediate Extended Wear of Two HOP/SiH Lenses.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Primary - Bacterial binding rates between test articles in both manners of wear - Daily wear and extended wear. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary - Corneal Epithelial thickness measures between test articles in both manners of wear - Daily wear and extended wear. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 187
Study Start Date: October 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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 bacterial binding to corneal cells and central epithelial thickness. Usual and customary care will be given in the form of eyeglasses and contact lenses. To compare long-term Daily wear vs. immediate Overnight wear (Extended wear) of a new hyper-oxygen permeable silicone hydrogel contact lens on binding of Pseudomonas Aeruginosa to exfoliated human surface corneal cells collected from the eyes of human patients and on central corneal thickness, as follows: 1) a hyper Dk/t lens for 12 months of daily wear, 2) a hyper Dk/t lens for 12 months of de novo 6 night extended wear, and 3) a hyper Dk/t lens for 12 months of de novo 30 night extended wear.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: 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 Criteria: 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344643

Locations
United States, Texas
University of Texas Southwestern Medical Center At Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
CIBA VISION
National Eye Institute (NEI)
Investigators
Principal Investigator: Harrison D Cavanagh, M.D., PhD University of Texas Southwestern Medical Center at Dallas
  More Information

No publications provided by University of Texas Southwestern Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: H. Dwight Cavanagh, UTSW Medical Center at Dallas
ClinicalTrials.gov Identifier: NCT00344643     History of Changes
Other Study ID Numbers: 0202-112
Study First Received: June 23, 2006
Last Updated: June 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Comparison of Daily wear versus Extended wear in bacterial binding and corneal epithelial thickness

ClinicalTrials.gov processed this record on May 23, 2013