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| ID | Type | Description | Link |
|---|---|---|---|
| P/438/13/L |
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The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AO for Astig / Biofinity Toric | Other | Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period. |
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| Biofinity Toric / AO for Astig | Other | Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B toric contact lens | Device | Commercially available, silicone hydrogel contact lens for correction of astigmatism |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Ocular Coma Score at 5mm Pupil at Day 30 | Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie Lemp, MS | Alcon Research | Study Director |
| Lyndon Jones, PhD | School of Optometry and Vision Science | Principal Investigator |
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Of the 49 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (40).
Participants were recruited from 1 study center located in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | AO for Astig / Biofinity Toric | Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2. |
| FG001 | Biofinity Toric / AO for Astig | Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 30 Days of Wear |
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| Washout Period, 1-13 Days |
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| Period 2, Second 30 Days of Wear |
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This analysis population includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
| 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 | Mean Ocular Coma Score at 5mm Pupil at Day 30 | Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean. | This analysis population includes all participants who completed the study. | Posted | Mean | Standard Deviation | micrometers | Day 30 |
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Adverse Events (AE) were collected for the duration of the study (5 months). An AE was defined as any undesirable medical occurrence which occurs in an individual participating in a clinical trial, whether or not it is considered to be trial-related.
This analysis population includes all participants dispensed with study products, based on treatment-specific exposure.
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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 | Air Optix for Astig | Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessie Lemp, GMA Brand Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Comfilcon A toric contact lens | Device | Commercially available, silicone hydrogel contact lens for correction of astigmatism |
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| NOT COMPLETED |
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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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Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days. |
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| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Biofinity Toric | Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days. | 0 | 38 | 0 | 38 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.