A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Study Overview
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Brief Summary
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The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

Official Title
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A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Investigational contact lens
* Device: PureVision contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have physiologically normal anterior segments Be adapted wearers of soft contact lenses and wear a lens in each eye. Be presbyopic and require near add correction in each eye. Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction. Have no active ocular disease or allergic conjunctivitis. Must not be using any topical ocular medications. Must habitually use a lens care product for lens cleaning, disinfecting, and storage. Exclusion Criteria: Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. Anisometropia (spherical equivalent) of greater than 2.00 D. Any systemic disease affecting ocular health. Using any systemic or topical medications that will affect ocular physiology or lens performance. Allergic to any component in the study products. Ocular astigmatism of greater than 1.00 D in either eye. Have had any corneal surgery (ie, refractive surgery). Uses AMO Ultra Care as their habitual lens care regimen. Is a toric contact lens wearer. Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months. An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.

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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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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational contact lens<br>multifocal high add soft contact lens | Device: Investigational contact lens<br>* Worn on a daily wear basis for one week.<br>|
| Active Comparator: PureVision contact lens<br>Multi-focal contact lens | Device: PureVision contact lens<br>* Worn on a daily wear basis for one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 2 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms/Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. | At 2 weeks follow up |