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This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.
The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) 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 | DDH contact lens for 15 minutes |
| |
| Lens B |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit Acceptance | Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator. | 15 minutes |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (DDH Contact Lens) | All participants wore Lens A for 15 minutes (Period 1) |
| FG001 | Lens B (DDSH Contact Lens) | 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, 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 | Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator. | All participants wore Lens A and Lens B in sequential order. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
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 that received Lens A | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| José A. Vega OD, MSc, FAAO | CooperVision, Inc. | 19256213761 | 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 | Jul 18, 2022 | Oct 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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All participants received Lens A and then Lens B in fixed-sequence order.
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| Device |
DDSH contact lens for 15 minutes |
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| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Lens B | Participants that received Lens B | 0 | 41 | 0 | 41 | 0 | 41 |
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