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The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.
This is a single-blind, interventional, prospective, direct refit, bilateral wear study.
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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 multifocal silicone hydrogel contact lens 15 minutes of daily wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Comfort Ratings on Insertion | Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel. | At insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubén V Guerrero, MSc, FIACLE | School of Optometry, National Autonomous University (UNAM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Optometry Clinic, National Autonomous University (UNAM) | Mexico City | Mexico |
Forty-two participants were screened. All participants wore Lens A first for 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) |
|
Overall study
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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 Comfort Ratings on Insertion | Subjective comfort ratings on insertion were measured on a scale from 0 - 10, where 0= extremely uncomfortable and 10= can't feel. | [Not Specified] | Posted | Mean | Standard Deviation | Units on scale | At insertion |
|
|
From dispense up to 15 minutes 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 15 minutes. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega,OD,MSc,FAAO | CooperVision | 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 | Apr 23, 2022 | Jul 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| 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 multifocal silicone hydrogel contact lens 15 minutes of daily wear |
|
| NOT COMPLETED |
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| 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 |
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| Counts |
|---|
| Participants |
|
|
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Lens B | Participants wore Lens B for 15 minutes. | 0 | 42 | 0 | 42 | 0 | 42 |
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