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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
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The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lotrafilcon B | Active Comparator | Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
|
| balafilcon A | Active Comparator | Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
|
| senofilcon A | Active Comparator | Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
|
| enfilcon A | Active Comparator | Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lotrafilcon B | Device | Commercially marketed, silicone hydrogel, spherical contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| On-eye Wettability | On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor. | 4 weeks of wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research: University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
This reporting group includes all enrolled and dispensed participants.
Four participants were enrolled but not dispensed due to failing inclusion/exclusion criteria (2) and withdrawing consent (2). These participants are included in the Actual Enrollment and Baseline Characteristics calculations, but not Participant Flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A | Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear. |
| FG001 | Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A | Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Four Weeks of Wear |
| |||||||||||||
| Second Four Weeks of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all enrolled subjects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| 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 | On-eye Wettability | On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor. | Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks of wear |
|
Adverse event data were collected for the duration of the trial: 166 days.
This reporting group includes all enrolled and exposed participants.
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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 | Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks. |
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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 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| balafilcon A | Device | Commercially marketed, silicone hydrogel, spherical contact lens |
|
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| senofilcon A | Device | Commercially marketed, silicone hydrogel, spherical contact lens |
|
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| enfilcon A | Device | Commercially marketed, silicone hydrogel, spherical contact lens |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
| OG002 | Senofilcon A | Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks. |
| OG003 | Enfilcon A | Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks. |
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Balafilcon A | Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks. | 0 | 23 | 0 | 23 |
| EG002 | Senofilcon A | Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks. | 0 | 23 | 0 | 23 |
| EG003 | Enfilcon A | Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks. | 0 | 23 | 0 | 23 |
No distribution of trial-specific information without express written permission of Director of Centre for Contact Lens Research.