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| Name | Class |
|---|---|
| University of Waterloo | OTHER |
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The purpose of this study is to assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon A | Active Comparator | Lotrafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. |
|
| Narafilcon A | Active Comparator | Narafilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. |
|
| Galyfilcon A | Active Comparator | Galyfilcon A, silicone hydrogel, spherical contact lens randomly assigned to one eye, worn on an extended wear basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narafilcon A contact lens | Device | Investigational, silicone hydrogel, spherical soft contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Front Surface Lens Deposits | Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe. | Period 2, Day 6 |
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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 |
Of the 57 subjects screened for the study, 11 did not start Period 1 due to personal reasons (7) and non-suitability (4). Period 1 established Day One measurements in order to monitor changes during Period 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Narafilcon A / Lotrafilcon A | Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear. |
| FG001 | Narafilcon A / Galyfilcon A | Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear. |
| FG002 | Lotrafilcon A / Galyfilcon A | Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, One Night of Wear |
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| Period 2, 7 Days/6 Nights of Wear |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed. |
| 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 | Front Surface Lens Deposits | Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe. | Per Protocol. Only the data from participants who completed all study visits were analyzed. | Posted | Mean | Standard Deviation | Units on a Scale | Period 2, Day 6 | Eyes | Participants |
|
Adverse event data were collected for the duration of the trial: 3 months.
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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 A | Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig Woods, PhD, FAAO / Research Manager | University of Waterloo | 1-519-888-4742 | cclr2@uwaterloo.ca |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon A contact lens | Device | Commercially marketed, silicone hydrogel, spherical soft contact lens |
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| Galyfilcon A contact lens | Device | Commercially marketed, silicone hydrogel, spherical soft contact lens |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Galyfilcon A | Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis. |
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|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Narafilcon A | Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis. | 0 | 30 | 0 | 30 |
| EG002 | Galyfilcon A | Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis. | 0 | 30 | 0 | 30 |
No distribution of trial-specific information without express written permission of director.