In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

Study Overview
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Brief Summary
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The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.

Detailed Description
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Non-dispensing, single-masked (subject-masked), randomised, controlled study.

Official Title
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Evaluation of Fit and Visual Acuity of the Cypress Toric Lens in Two Phases: Part A: A Non-Dispensing Comparison to SofLens66® Toric and Acuvue® 2

Conditions
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Astigmatism

Intervention / Treatment
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* Device: senofilcon A toric contact lens
* Device: alphafilcon A toric
* Device: etafilcon A sphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed). be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study. be able and willing to adhere to the instructions set forth in the protocol. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye. be in good general health, based on his/her knowledge. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT. Exclusion Criteria: The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc). Slit lamp findings that would contraindicate contact lens wear such as: Pathological dry eye or associated findings Pterygium or corneal scars within the visual axis Neovascularization >1mm in from the limbus History of giant papillary conjunctivitis (GPC) worse than Grade 2 Anterior uveitis or iritis (past or present) Seborrhoeic eczema, seborrhoeic conjunctivitis A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections. A known history of corneal hypoesthesia (reduced corneal sensitivity.) Aphakia, keratoconus or a highly irregular cornea. Current pregnancy or lactation (to the best of the subject's knowledge). Active participation in another clinical study at any time during this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: senofilcon A/alphafilcon A/etafilcon A<br>First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses | Device: senofilcon A toric contact lens<br>* contact lens<br>Device: alphafilcon A toric<br>* contact lens<br>Device: etafilcon A sphere<br>* contact lens<br>|
| Active Comparator: alphafilcon A/etafilcon A/senofilcon A<br>First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses | Device: senofilcon A toric contact lens<br>* contact lens<br>Device: alphafilcon A toric<br>* contact lens<br>Device: etafilcon A sphere<br>* contact lens<br>|
| Active Comparator: etafilcon A/senofilcon A/alphafilcon A<br>First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses | Device: senofilcon A toric contact lens<br>* contact lens<br>Device: alphafilcon A toric<br>* contact lens<br>Device: etafilcon A sphere<br>* contact lens<br>|
| Active Comparator: senofilcon A/etafilcon A/alphafilcon A<br>First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses | Device: senofilcon A toric contact lens<br>* contact lens<br>Device: alphafilcon A toric<br>* contact lens<br>Device: etafilcon A sphere<br>* contact lens<br>|
| Active Comparator: alphafilcon A/senofilcon A/etafilcon A<br>First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses | Device: senofilcon A toric contact lens<br>* contact lens<br>Device: alphafilcon A toric<br>* contact lens<br>Device: etafilcon A sphere<br>* contact lens<br>|
| Active Comparator: etafilcon A/alphafilcon A/senofilcon A<br>First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses | Device: senofilcon A toric contact lens<br>* contact lens<br>Device: alphafilcon A toric<br>* contact lens<br>Device: etafilcon A sphere<br>* contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Number of eyes with Distance Visual Acuity 20/20 or better | 15-20 minutes | 
| Patient Reported Vision | A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. >0=greater vision, <0=lesser vision. | 15-20 minutes | 
| Lens Orientation Within 5 Degrees | Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation. | 1 minute | 
| Lens Stability Within 5 Degrees | Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation. | 1 minute | 
| Patient Reported Comfort. | 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, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. >0=comfortable, <0=uncomfortable | 15-20 minutes | 
| Patient Preference | This outcome measures which lens the subjects preferred to wear. | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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astigmatism, visual acuity, fit, comfort, satisfaction, contact lens