Expired Study
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Warren, Ohio 44484


Purpose:

Evaluate and compare the clinical performance of three toric contact lenses amongst 660 subjects, 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study. Hypotheses include equal or better performance of the test lens over the control lenses for comfort, vision, and toric fit characteristics, as well as corneal integrity. As of May 7, 2008 study will consist of no more than 330 eligible subjects.


Study summary:

Up to 44 sites, 22 in the US and 22 in Canada will participate. Each investigator will only use one control lens type, though all sites will have the test lens. There will be a maximum of 4 scheduled visits: Visit 1: Habitual lens evaluation / Baseline / Trial fitting Visit 2: Dispensing (to be combined with Visit 1 where possible) Visit 3: Questionnaire only (no exam) 7 days (±2) after dispensing Visit 4: 2 week follow-up 14 days (±3) after dispensing As of May 7, 2008 study will consist of 22 sites in the US only.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT00638846


Primary Contact:

Study Director
Graeme YOung, MPhil PhD


Backup Contact:

N/A


Location Contact:

Warren, Ohio 44484
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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