Performance of Two Silicone Hydrogel Toric Contact Lenses
NCT ID: NCT00638846
Last Updated: 2015-05-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
276 participants
INTERVENTIONAL
2008-02-29
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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senofilcon A toric
senofilcon A, daily wear, toric contact lens worn for two weeks
senofilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
balafilcon A toric
balafilcon A, daily wear, toric contact lens worn for two weeks
balafilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Interventions
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senofilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
balafilcon A toric
silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sign Written Informed Consent (See separate document).
* Be an existing successful daily wear toric soft contact lens.
* Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
* Does not require presbyopic correction (can read J1 @ normal reading distance).
* Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
* Have refractive astigmatism between 0.75D and 2.50D in both eyes.
* Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
* 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.
* No conjunctival abnormality or infection.
* No clinically significant slit lamp findings (i.e. stromal edema, vascularisation, infiltrates or abnormal opacities).
* No other active ocular disease.
Exclusion Criteria
* Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Corneal staining Grade 3 in more than one region.
* Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
* Extended lens wear in last 3 months.
* 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., HIV).
* Pregnancy, lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 60 days.
18 Years
45 Years
ALL
Yes
Sponsors
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Johnson & Johnson Vision Care, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Graeme YOung, MPhil PhD
Role: STUDY_DIRECTOR
Locations
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Camp Eye Care Clinic
North Little Rock, Arkansas, United States
James R. Dugue, O.D.
Mission Viejo, California, United States
Executive Park Eye Care
Colorado Springs, Colorado, United States
Dr. Ted Brink and Associates
Jacksonville, Florida, United States
Grene Vision Group
Neodesha, Kansas, United States
Advanced Eyecare, PC
Raytown, Missouri, United States
Dr. James Brobst
Florence, New Jersey, United States
Fine Eye Care Associates
Rochester, New York, United States
Warren Ophthalmology Associates
Warren, Ohio, United States
Selden Eyecare LLC
Kittanning, Pennsylvania, United States
Nittany Eye Associates
State College, Pennsylvania, United States
Dr. David W. Ferris and Associates
Warwick, Rhode Island, United States
Dr. Larry Menning
Chamberlain, South Dakota, United States
Wishnow-Sugar Vision Group
Katy, Texas, United States
Dr. William Bogus
Salt Lake City, Utah, United States
Midlothian Optometric Center
Midlothian, Virginia, United States
The Eye Specialists, Ltd.
Virginia Beach, Virginia, United States
The Eye & Contact Lens Clinic
Bremerton, Washington, United States
Matus Eyecare
Franklin, Wisconsin, United States
Countries
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Other Identifiers
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CTOR-501
Identifier Type: -
Identifier Source: secondary_id
CR-0801
Identifier Type: -
Identifier Source: org_study_id
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