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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| omafilcon A / PC 1-D MF | Active Comparator | 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. |
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| lotrafilcon B / Air Optix MF | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omafilcon A / PC 1-D MF | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
To be eligible for the study, each candidate must not present with any of the following
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| Name | Affiliation | Role |
|---|---|---|
| Peter Kollbaum, OD, PhD | Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab, Indiana University, | Bloomington | Indiana | 47405 | United States |
The subjects who are current contact lens wearers should attend the first visit wearing their habitual lenses and having worn them that day for at least 2 hours prior to the visit.
Recruitment was open between 06FEB2012 and 28FEB2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF) | Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application). |
| FG001 | Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF) | Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per Protocol | Posted | Mean | Standard Deviation | logMAR units | After 1 hour of lens wear |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omafilcon A / PC1DMF L2A (TEST) | Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pete Kollbaum, OD, PhD, FAAO, FBCLA, Principal Investigator | Indiana University | 812-856-0108 | kollbaum@indiana.edu |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| lotrafilcon B / Air Optix MF | Device | 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 |
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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 |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | Per Protocol | Posted | Mean | Standard Deviation | units on a scale | After 1 hour of lens wear |
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| Secondary | 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. | Per Protocol | Posted | Mean | Standard Deviation | units on a scale | After 1 hour of lens wear |
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| Primary | 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. | Per Protocol | Posted | Mean | Standard Deviation | logMAR units | After 1 hour of lens wear |
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| Primary | 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. | Per Protocol | Posted | Mean | Standard Deviation | logMAR units | After 1 hour of lens wear |
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| Secondary | 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. | Per Protocol | Posted | Mean | Standard Deviation | units on a scale | After 1 hour of lens wear |
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| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Lotrafilcon B / Air Optix MF (CONTROL) | Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses. | 0 | 49 | 0 | 49 |
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