Clinical Evaluation of Two Toric Contact Lenses in Current Non-toric Lens Users

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical performance, defined as successful fit, of two toric contact lenses (one daily disposable and the other daily wear reusable contact lens to correct astigmatism) in current spherical soft contact lens wearers, contact lens drop-outs, and non-users of toric contact lenses (neophytes).

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Senofilcon A Toric (AOfA)
* Device: Etafilcon A Toric (1DAMfA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must satisfy the following conditions prior to inclusion in the study: One of the following: Spherical contact lens user (minimum of 2 months wear, four days a week, 8 hours a day) Contact Lens drop-out (no contact lens wear in the last 6 months but wearing glasses at least four days a week,8 hours a day) Neophyte (no habitual contact lens wear except for trial fits up to 1 week, but wearing glasses at least four days a week,8 hours a day For patients not currently wearing lenses, patient should have expressed a desire to try lenses. Between 16 and 60 years of age. Have signed an informed consent form (documented by the investigator in the Case Report Form [CRF]). Distance requirement in the range of +4.00D to -9.00D (i.e. -10.00D refractive) Refractive astigmatism between -0.75D and -3.00D in both eyes. Have best corrected VA of 6/9 (20/30) or better in each eye. Have normal eyes with no evidence of abnormality or disease. For the purpose 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 haze, staining, scarring, vascularisation, infiltrates or abnormal opacities). No other active ocular disease. Presbyopes may be included (no monovision, no spectacles over contact lenses or bifocal glasses only) Exclusion Criteria: Any of the following will render a subject ineligible for inclusion: Requires concurrent ocular medication. Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperaemia, limbal hyperaemia, or any other abnormality of the cornea that would contraindicate contact lens wear. Corneal staining Grade 3 in more than two regions. Extended wear in the last 3 months. Has had any anterior ocular surgery. Has had any other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study. Abnormal lachrymal secretions. Pre-existing ocular irritation that would preclude contact lens fitting. Keratoconus or other corneal irregularity. Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Has diabetes. Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV). Pregnancy, lactating, or planning a pregnancy at the time of enrollment. Participation in any concurrent clinical trial or in last 60 days.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spherical contact lens users<br>Habitual spherical contact lens (non-toric lens) users tried one of two toric lenses in a daily wear modality. | Device: Senofilcon A Toric (AOfA)<br>* Soft toric contact lenses for astigmatism<br>Device: Etafilcon A Toric (1DAMfA)<br>* Soft toric contact lenses for astigmatism<br>|
| Other: Contact lens drop-outs<br>Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, tried one of two toric lenses in a daily wear modality. | Device: Senofilcon A Toric (AOfA)<br>* Soft toric contact lenses for astigmatism<br>Device: Etafilcon A Toric (1DAMfA)<br>* Soft toric contact lenses for astigmatism<br>|
| Other: Habitual Correction with Spectacles (Neophytes)<br>Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses tried one of two toric lenses in a daily wear modality. | Device: Senofilcon A Toric (AOfA)<br>* Soft toric contact lenses for astigmatism<br>Device: Etafilcon A Toric (1DAMfA)<br>* Soft toric contact lenses for astigmatism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success in Fitting With a Toric Contact Lens | Percent of subjects with success with toric lens fitting defined as meeting all of the following pre-determined criteria: 1) acceptable fit, 2) orientation stability less than or equal to 20 degree rotation, 3) binocular visual acuity (VA) within one line of spectacle VA, 4) Good, very good, or excellent overall quality of Vision, and 5) good, very, good, or excellent overall lens comfort. There was not an inferential statistical analysis conducted on this outcome. Comparison was made through the use of 95% CI's for the proportions. Therefore no statistical analysis section is included for this primary outcome. | 4 weeks | 
| Distance Visual Acuity | Measured monocularly (each eye separately) in Snellen converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction. | after 1 week of toric contact lens wear | 
| Distance Visual Acuity (VA) | Visual Acuity is measured monocularly (each eye separately) in Snellen, the converted to logMAR units. The logMAR scale has a range of -0.30 to 1.00. A value of 0 or less would not require distance vision correction and a value of 0 or greater may require distance vision correction. | after 4 weeks of toric contact lens wear |