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The purpose of this study was to compare visual performance measures between two multifocal contact lenses on presbyopic wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon B / Comfilcon A | Other | Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. |
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| Comfilcon A / Lotrafilcon B | Other | Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lens | Device | Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use. |
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| Measure | Description | Time Frame |
|---|---|---|
| Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. | 1 week |
| Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacie Cummings, O.D. | Alcon Research | Study Director |
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Five participants were enrolled, but not dispensed, due to failing inclusion/exclusion criteria (4) and unacceptable subjective vision (1). Baseline characteristics are presented on all enrolled and dispensed participants: 104.
Participants were recruited and enrolled from 12 US private practices.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B / Comfilcon A | Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. |
| FG001 | Comfilcon A / Lotrafilcon B | Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One: One Week |
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| Period Two: One Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled and dispensed participants |
| 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 Continuous | Mean |
| 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 | Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity | The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | logMAR | 1 week |
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Adverse events were collected for the duration of the study: 24-JUN-2011 to 16-AUG-2011.
The safety population included all enrolled and dispensed participants. One participant was dispensed the control product only in this cross-over study.
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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 | Lotrafilcon B | Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacie Cummings, O.D. | Alcon Research, Ltd. | 1-800-241-7629 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Comfilcon A contact lens | Device | Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use. |
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| NOT COMPLETED |
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| 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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| OG001 | Comfilcon A | Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week. |
|
|
| Primary | Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity. | The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit. | Posted | Mean | Standard Deviation | logMAR | 1 week |
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| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Comfilcon A | Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week. | 0 | 104 | 0 | 104 |
For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.