Status:
COMPLETED
Performance of Two Silicone Hydrogel Toric Contact Lenses
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Vision Correction
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00638846
Start Date
February 1 2008
End Date
May 1 2008
Last Update
May 21 2015
Active Locations (19)
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1
Camp Eye Care Clinic
North Little Rock, Arkansas, United States, 72116
2
James R. Dugue, O.D.
Mission Viejo, California, United States, 92691
3
Executive Park Eye Care
Colorado Springs, Colorado, United States, 80909
4
Dr. Ted Brink and Associates
Jacksonville, Florida, United States, 32256