Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

Study Overview
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Brief Summary
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This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

Detailed Description
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The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Official Title
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Clinical Evaluation of Proclear Monthly and Avaira Vitality

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Device: Lens A
* Device: Lens B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is at least 18 years of age and has full legal capacity to volunteer. Has read and signed an information consent letter. Self-reports having a full eye examination in the previous two years. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week. Is willing and able to follow instructions and maintain the appointment schedule. Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum. Has refractive astigmatism no higher than -0.75DC. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS) Exclusion Criteria: Is participating in any concurrent clinical or research study. Has any known active ocular disease and/or infection that contraindicates contact lens wear. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. Has known sensitivity to the diagnostic sodium fluorescein used in the study. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. Has undergone refractive error surgery or intraocular surgery.

Ages Eligible for Study
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Minimum Age: 18 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: All participants received Lens A and then Lens B in fixed-sequence order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens A<br>All participants wore Lens A for 15 minutes (Period 1) | Device: Lens A<br>* Soft spherical hydrogel contact lens for 15 minutes<br>|
| Experimental: Lens B<br>All participants wore Lens B for 15 minutes (Period 2) | Device: Lens B<br>* Soft spherical silicone hydrogel contact lens for 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Fit Acceptance Rating | Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator. | 15 minutes |