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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 sphere contact lenses.
The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A (ocufilcon D) | Experimental | All participants will wear lens A for 15 minutes (Period 1). |
|
| Lens B (fanfilcon A) | Experimental | All participants will wear lens B for 15 minutes (Period 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (ocufilcon D) | Device | 15 minutes of daily wear. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit Acceptance Ratings | Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect) | At the end of 15 Minutes of wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Guerrero, MSc, FIACLE | National Autonomous University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultorio Optométrico Queretaro | Mexico City | 06760 | Mexico |
Forty-four participants were screened and dispensed lenses. All participants who were dispensed with lenses completed the study. (n=44)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (Ocufilcon D) | All participants wore lens A for 15 minutes (Period 1). Lens A (ocufilcon D): 15 minutes of daily wear. |
| FG001 | Lens B (Fanfilcon A) | All participants wore lens B for 15 minutes (Period 2). Lens B (fanfilcon 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 |
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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 | Lens Fit Acceptance Ratings | Overall lens fit acceptance was measured on a scale from 0-4 (0=Should not be worn and 4= Perfect) | All the forty-four participants who started the study, completed the study. | Posted | Mean | Standard Deviation | Units on Scale | At the end of 15 Minutes of wear |
|
Through study completion, approximately five 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 (Ocufilcon D) | All participants wore lens A for 15 minutes (Period 1). Lens A (ocufilcon D): 15 minutes of daily wear. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, MSc, FAAO | CooperVision, Inc. | 925-621-3761 | javega@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 | Feb 6, 2024 | May 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Lens B (fanfilcon 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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| Units | Counts |
|---|---|
| Participants |
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|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Lens B (Fanfilcon A) | All participants wore lens B for 15 minutes (Period 2). Lens B (fanfilcon A): 15 minutes of daily wear. | 0 | 44 | 0 | 44 | 0 | 44 |
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