An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.

Study Overview
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Brief Summary
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This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.

Detailed Description
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This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).

Official Title
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An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.

Conditions
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Myopia

Intervention / Treatment
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* Device: First pair Senofilcon A contact lens
* Device: Second pair Senofilcon A contact lens
* Device: Third pair Senofilcon A contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-70 years. Able to read, comprehend and sign an informed consent. Willing to comply with the wear and study assessment schedule. Spherical distance prescription between -0.50 and -6.00 (inc.). Astigmatism, if present,≤1.50DC in both eyes. Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia). Exclusion Criteria: Previous anterior ocular surgery Any active corneal infection, injury or inflammation . •Large pinguecula likely to affect soft lens fit Systemic or ocular disease or medication which might interfere with CL wear Pregnancy or breastfeeding Participation in any concurrent trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each subject will wear the three contact lens types bilaterally in random succession
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First Pair Senofilcon A contact lens<br>The first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal. | Device: First pair Senofilcon A contact lens<br>* Fit assessment of the first pair contact lenses.<br>|
| Active Comparator: Second pair Senofilcon A contact lens<br>The second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal. | Device: Second pair Senofilcon A contact lens<br>* Fit assessment of the second pair of contact lenses.<br>|
| Active Comparator: Third pair Senofilcon A contact lens<br>The third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal. | Device: Third pair Senofilcon A contact lens<br>* Fit assessment of the third pair of contact lenses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens fit (position on the eye) in mm | Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm), | 25 minutes | 
| Lens edge tightness fit grade 0-4 | Edge tightness (grade 0-4) | 5 minutes | 
| Lens tightness fit graded as % | Tightness (push-up %), | 5 minutes | 
| Lens overall fit grade 0-5 | Overall fit acceptability (Grade 0-5), | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact lens, The Young Theory