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The purpose of this trial is to compare the performance of two multifocal contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon B / Senofilcon A | Other | Lotrafilcon B, followed by Senofilcon A |
|
| Senofilcon A / Lotrafilcon B | Other | Senofilcon A, followed by Lotrafilcon B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B multifocal contact lens | Device | Silicone hydrogel, soft, multifocal contact lens for daily wear use |
|
| 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 |
| Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | Tested while reading charts at 40 cm 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Two participants were enrolled but not dispensed due to failing inclusion criteria. These participants were included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B / Senofilcon A | Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis. |
| FG001 | Senofilcon A / Lotrafilcon B | Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled and dispensed subjects |
| 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 | 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. | Per protocol. Analysis excluded major protocol deviations as determined by masked review. | Posted | Mean | Standard Deviation | LogMAR | After 1 week of wear |
|
9 weeks, duration of the study
1 week of wear for each intervention
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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 Multifocal Contact Lens | Silicone hydrogel, soft, multifocal contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs | CIBA VISION | 1-800-241-7629 | priya.janakiraman@cibavision.com |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Senofilcon A multifocal contact lens | Device | Silicone hydrogel, soft, multifocal contact lens for daily wear use |
|
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Senofilcon A Multifocal Contact Lens |
Silicone hydrogel, soft, multifocal contact lens |
|
|
| Primary | Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity | Tested while reading charts at 40 cm 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. | Per protocol. Analysis excluded major protocol deviations as determined by masked review. | Posted | Mean | Standard Deviation | LogMAR | After 1 week of wear |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Senofilcon A Multifocal Contact Lens | Silicone hydrogel, soft, multifocal contact lens | 0 | 38 | 0 | 38 |
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 pre-clinical and/or clinical data or impressions from this trial.