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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.
The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A (omafilcon B) | Experimental | All participants will wear lens A for 15 minutes (Period 1). |
|
| Lens B (comfilcon A) | Experimental | All participants will wear lens B for 15 minutes (Period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (omafilcon B) | Device | 15 minutes of daily wear. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Fit Acceptance | Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect) | After 15 minutes of continuous wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | Centre for Ocular Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Canada |
Thirty-eight Participants were screened. One Participant was not eligible due to screening failure.
All the participants who were eligible in the study were included in the analysis. (n=37)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (Omafilcon B) | All participants wore lens A for 15 minutes (Period 1). Lens A (omafilcon B): 15 minutes of daily wear. |
| FG001 | Lens B (Comfilcon A) | All participants wore lens B for 15 minutes (Period 2). Lens B (comfilcon A): 15 minutes of daily wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Lens A (15 Minutes) |
| |||||||||||||
| Period 2: Lens B (15 Minutes) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Includes all Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Overall Fit Acceptance | Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect) | All the participants who were eligible in the study were included in the analysis. (n=37) | Posted | Mean | Standard Deviation | Units on Scale | After 15 minutes of continuous wear |
|
Through study completion, approximately 23 weeks
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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 | Lens A (Omafilcon B) | All participants wore lens A for 15 minutes (Period 1). Lens A (omafilcon B): 15 minutes of daily wear. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A Vega, OD,MSc,PhD | CooperVision Inc. | 925-621-3761 | JVega2@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2024 | May 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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Single
| Lens B (comfilcon A) |
| Device |
15 minutes of daily wear. |
|
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Lens B (Comfilcon A) | All participants wore lens B for 15 minutes (Period 2). Lens B (comfilcon A): 15 minutes of daily wear. | 0 | 37 | 0 | 37 | 0 | 37 |
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