A Clinical Comparison of Two Soft Contact Lenses

Study Overview
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Brief Summary
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The study objective was to gather short-term clinical performance data for two soft contact lenses.

Detailed Description
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The aim of this study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Official Title
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A Clinical Comparison of Two Soft Contact Lenses

Conditions
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Myopia, Hyperopia

Intervention / Treatment
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* Device: Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1
* Device: Daily Disposable Spherical Silicone Hydrogel Contact Lens 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are of legal age (18) and capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They currently wear soft contact lenses, or have done so within the past two years. They are expected to be able to be fitted with the study lenses within the power range available. Exclusion Criteria: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They are aphakic. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or lactating. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1<br>Subjects will wear Monthly Replacement Silicone Hydrogel Contact Lens 1 for the first period of 15 minutes and Daily Disposable Spherical Silicone Hydrogel Contact Lens 2 for the second period of 15 minutes. | Device: Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1<br>* Monthly Replacement Spherical Silicone Hydrogel Contact Lens 1 - first period of 15 minutes<br>|
| Experimental: Daily Disposable Silicone Hydrogel Contact Lens 2<br>Subjects will wear Daily Disposable Spherical Silicone Hydrogel Contact Lens 2 for the second period of 15 minutes. | Device: Daily Disposable Spherical Silicone Hydrogel Contact Lens 2<br>* Daily Disposable Spherical Silicone Hydrogel Contact Lens 2 - second period of 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Score | Subjective overall score will be assessed using 0-100 visual analogue scale (0=Extremely poor. Cannot use lenses. and 100=Excellent. Highly impressed with these lenses overall.) | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort | Subjective comfort score will be assessed using 0-100 visual analogue scale (0=Causes pain. Cannot be tolerated.; 100=Excellent. Cannot be felt.) | 15 minutes | 
| Subjective Vision | Subjective vision score will be assessed using 0-100 visual analogue scale (0=Unacceptable. Lens cannot be worn.; 100=Excellent. Unaware of any visual loss.) | 15 minutes |