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The purpose of this study was to evaluate the clinical performance and subjective lens handling (insertion and removal) of two toric silicone hydrogel contact lenses after one month of daily wear each.
This was a prospective, randomized, double masked, bilateral, crossover study. Participants were expected to attend 6 scheduled visits over a period of approximately 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A, then Lens B | Experimental | Participants wore Lens A for one month and then wore Lens B for one month. |
|
| Lens B, then Lens A | Experimental | Participants wore Lens B for one month and then wore Lens A for one month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A (fanfilcon A) | Device | Daily wear for one month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling (Insertion and Removal) | Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance. | 1 month |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Rubén Velázquez Guerrero, MSc, FIACLE | National Autonomous University (UNAM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Autonomous University (UNAM) | Mexico City | Código | 54090 | Mexico |
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This study was conducted at a single investigative site located in Mexico City, Mexico.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A, Then Lens B | Participants first wore Lens A for one month and then wore Lens B for one month. |
| FG001 | Lens B, Then Lens A | Participants first wore Lens B for one month and then wore Lens A for one month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (One Month) |
| |||||||||||||
| Period 2 (One Month) |
|
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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 | Lens Handling (Insertion and Removal) | Subjective lens handling measured ease of insertion and removal on a scale of 0-10, where 10=better performance. | All participants who were exposed to study lenses and completed each study visit. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
For the duration of the study, approximately two 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 | Lens A | Participants that received Lens A during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega OD, MSc, FAAO | CooperVision Inc. | 9256213761 | 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 | Aug 19, 2021 | May 23, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B (asmofilcon A) | Device | Daily wear for one month |
|
| NOT COMPLETED |
|
| years |
|
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Lens B | Participants that received Lens B during either the first or second period of the study. | 0 | 36 | 0 | 36 | 0 | 36 |
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