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The study objective was to compare short-term clinical performance data of two toric contact lenses.
The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of a monthly toric contact lens when compared to a daily disposable toric contact lens after 15 minutes of daily wear each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A | Experimental | All participants wore Lens A for 15 minutes (Period 1) |
|
| Lens B | Experimental | All participants wore Lens B for 15 minutes (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A | Device | Monthly Replacement Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Handling Ratings on Insertion | Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance | At insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubén V Guerrero, MSc., FIACLE | Dr. Ruben Velazquez Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Ruben Velazquez Private Practice | Mexico City | 06700 | Mexico |
Forty-two participants were screened. All participants wore Lens A for first 15 minutes and then wore Lens B for 15 minutes.
All the participants who were in the study were included in the analysis. (n=42)
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A | All participants wore Lens A for 15 minutes. (Period 1) |
| FG001 | Lens B | All participants wore Lens B for 15 minutes. (Period 2) |
| 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, Categorical | Count of Participants |
| 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 | Subjective Handling Ratings on Insertion | Subjective handling ratings on insertion will be measured on a scale from 0-100, where (0= extremely uncomfortable) and 100 = better performance | [Not Specified] | Posted | Mean | Standard Deviation | units on a scale | At insertion |
|
From dispense up to 15mins on each lens type.
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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 wore Lens A for 15mins. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, OD, MSc, FAAO | CooperVision | 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 | Jun 16, 2022 | Jul 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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All participants received Lens A and then Lens B in fixed-sequence order.
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| Lens B | Device | Daily Disposable Toric Silicone Hydrogel Contact Lens 15 minutes of daily wear |
|
| NOT COMPLETED |
|
| Participants |
|
| 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 |
|
|
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Lens B | Participants wore Lens B for 15mins. | 0 | 42 | 0 | 42 | 0 | 42 |
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