Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens

Study Overview
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Brief Summary
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The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.

Official Title
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Lotrafilcon B Multifocal Evaluations - Comparison to a Traditional Multifocal in Higher Spectacle Adds

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Lotrafilcon B multifocal contact lens
* Device: Omafilcon A multifocal contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 35 years of age. Best-corrected visual acuity of at least 20/40 in each eye. Spectacle add from +1.50D and +2.50D (inclusive). Able to be fit in available study sphere powers (Plano to -4.00D). Currently wearing soft contact lenses at least 5 days a week. Other protocol inclusion / exclusion criteria may apply. Exclusion Criteria: Requires concurrent ocular medication. Eye injury or surgery within twelve weeks immediately prior to enrollment. Currently enrolled in an ophthalmic clinical trial. Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. Previous refractive surgery. Astigmatism > 1.00D. Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses. Other protocol inclusion / exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lotrafilcon B / Omafilcon A<br>Lotrafilcon B, followed by Omafilcon A | Device: Lotrafilcon B multifocal contact lens<br>* Silicone hydrogel, soft, multifocal contact lens for daily wear use<br>Device: Omafilcon A multifocal contact lens<br>* Hydrogel, soft, multifocal contact lens for daily wear use<br>|
| Other: Omafilcon A / Lotrafilcon B<br>Omafilcon A, followed by Lotrafilcon B | Device: Lotrafilcon B multifocal contact lens<br>* Silicone hydrogel, soft, multifocal contact lens for daily wear use<br>Device: Omafilcon A multifocal contact lens<br>* Hydrogel, soft, multifocal contact lens for daily wear use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | Tested while reading charts distant to the subject with both eyes together in normal lighting. This outcome is measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 equates to 20/20 Snellen acuity and is considered normal. Positive logMAR values indicate poorer vision and negative values denote better visual acuity. | After 1 week of wear |