Performance of Two Silicone Hydrogel Toric Contact Lenses

Completed · Not applicable

Conditions studied: Vision Correction

In brief

Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.

Key facts

Study ID: NCT00638846
Run by: Johnson & Johnson Vision Care, Inc.
People needed: 276
Starts: 2008-02-01
Expected to finish: 2008-05-01
Last updated by the study team: 2015-05-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Be between 18 and 45 years of age.
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.

You may not qualify if…

Requires concurrent ocular medication.
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.

Where it is running

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

Full record on ClinicalTrials.gov

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