Performance of Two Silicone Hydrogel Toric Contact Lenses

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

Official Title
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Multi-Center Evaluation Of Two Silicone Hydrogel Toric Contact Lenses

Conditions
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Vision Correction

Intervention / Treatment
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* Device: senofilcon A toric
* Device: balafilcon A toric


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: senofilcon A toric<br>senofilcon A, daily wear, toric contact lens worn for two weeks | Device: senofilcon A toric<br>* silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)<br>* Other names: ACUVUE OASYS;|
| Active Comparator: balafilcon A toric<br>balafilcon A, daily wear, toric contact lens worn for two weeks | Device: balafilcon A toric<br>* silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement)<br>* Other names: PureVision Toric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Orientation | Proportion of eyes with lens orientation within 5 degrees of optimal | 1 minute after insertion | 
| Lens Stability | Lens stability is measured as the amount of rotation induced from blink after the lens has settled. | 10-15 minutes after insertion | 
| Subjective Comfort | Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5. | 2 weeks of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Fit Lens | Time required for the optometrist to fit the lens. | after lens insertion | 
| Subjective Lens Vision | A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data. | measured at 1 and 2 weeks | 
| Overall Corneal Staining | National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. | After 2 weeks use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toric contact lenses, vision, comfort, toric fit characteristics, slit lamp findings