Proclear 1-D Multifocal Nondispensing Study

Study Overview
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Brief Summary
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This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

Detailed Description
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The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

Official Title
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Proclear 1-D Multifocal Nondispensing Study

Conditions
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Presbyopia

Intervention / Treatment
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* Device: omafilcon A / PC 1-D MF
* Device: lotrafilcon B / Air Optix MF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 40 and 65 years of age (inclusive) Require a reading addition of +1.25 to +2.50D (inclusive) Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive) Spectacle cylinder less than or equal to 0.75D in both eyes. Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read) Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D) Have a minimum 2 weeks soft contact lens experience Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study) Able to read, comprehend and sign an informed consent Willing to comply with the wear and study visit schedule Monocular best-corrected distance visual acuity ≥ 20/25 in each eye No gas permeable contact lens wear for 1 month prior to the study Exclusion Criteria: To be eligible for the study, each candidate must not present with any of the following Any active corneal infection, injury, inflammation, or ocular abnormality Systemic or ocular allergies, which might interfere with contact lens wear Systemic disease, which might interfere with contact lens wear Ocular disease, which might interfere with contact lens wear Pregnant or lactating Strabismus/amblyopia Habitually uncorrected anisometropia greater than or equal to 2.00 D Subjects who have undergone corneal refractive surgery Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: omafilcon A / PC 1-D MF<br>omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. | Device: omafilcon A / PC 1-D MF<br>* Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.<br>* Other names: Proclear Multifocal daily wear soft contact lenses;Device: lotrafilcon B / Air Optix MF<br>* Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses<br>* Other names: Air OPtix Aqua Multifocal extended wear soft contact lenses;|
| Active Comparator: lotrafilcon B / Air Optix MF<br>lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF) Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses. | Device: omafilcon A / PC 1-D MF<br>* Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.<br>* Other names: Proclear Multifocal daily wear soft contact lenses;Device: lotrafilcon B / Air Optix MF<br>* Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses<br>* Other names: Air OPtix Aqua Multifocal extended wear soft contact lenses;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Vision Assessments: High Contrast Distance Visual Acuity | Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value. | After 1 hour of lens wear | 
| Objective Vision Assessments: High Contrast Intermediate Visual Acuity | Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value. | After 1 hour of lens wear | 
| Objective Vision Assessments: High Contrast Near Visual Acuity | Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value. | After 1 hour of lens wear | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Vision: High Contrast Distance Visual Quality | Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent. | After 1 hour of lens wear | 
| Subjective Vision Assessments: High Contrast Intermediate Visual Quality | Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent. | After 1 hour of lens wear | 
| Subjective Vision Assessments: High Contrast Near Visual Quality | Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent. | After 1 hour of lens wear | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contact lenses