A Clinical Comparison of Two Soft Multifocal 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 multifocal contact lenses.

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

Official Title
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A Clinical Comparison of Two Soft Multifocal Contact Lenses

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Soft Multifocal Hydrogel Contact Lens 1
* Device: Soft Multifocal Silicone Hydrogel Contact Lens 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are at least 42 years of age and have capacity to volunteer. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They have had a full eye examination within past two years (by self-report) They are willing and able to follow protocol. They habitually use vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or have a different spectacle prescription for distance and near vision correction) and have done so for at least the past three months. They have refractive astigmatism of no greater than -0.75DC. They are expected to be able to fitted with the study lenses within power range available, and to achieve binocular distance HCVA of +0.20 or better in the study lenses. 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 risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

Ages Eligible for Study
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Minimum Age: 42 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 |
| --- | --- |
| Experimental: Soft Multifocal Hydrogel Contact Lens 1<br>Participants will wear soft multifocal hydrogel contact lens 1 for the first period of 15 minutes and soft multifocal silicone hydrogel contact lens 2 for the second period of 15 minutes. | Device: Soft Multifocal Hydrogel Contact Lens 1<br>* soft multifocal hydrogel contact lens 1 - first period of 15 minutes<br>|
| Experimental: Soft Multifocal Silicone Hydrogel Contact Lens 2<br>Participants will wear soft multifocal silicone hydrogel contact lens 2 for the second period of 15 minutes. | Device: Soft Multifocal Silicone Hydrogel Contact Lens 2<br>* soft multifocal 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 the 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 the 0-100 visual analogue scale (0= Causes pain. Cannot be tolerated. and 100=Excellent. Cannot be felt.) | 15 Minutes | 
| Subjective Vision | Subjective Vision Score will be assessed using the 0-100 visual analogue scale (0= Unacceptable. Cannot be worn. and 100=Excellent. Unaware of any visual loss.) | 15 Minutes |