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This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.
The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses 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 | Soft spherical hydrogel contact lens for 15 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit Acceptance Rating | Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum 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 |
|---|---|---|
| Juan G Carracedo Rodríguez, OD,MSc,PhD | University Complutense of Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Complutense of Madrid | Madrid | 28037 | Spain |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (Hydrogel Contact Lens) | All participants wore Lens A for 15 minutes (Period 1) |
| FG001 | Lens B (Silicone Hydrogel 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 Participants | All participants who enrolled and completed all study visits. |
| 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 Rating | Measured on lens fit alone on a scale of 0-4 (0=Should not be used; 1=Limit, but unacceptable; 2=Minimum acceptable, early review; 3=Not perfect, but OK to dispense; 4=Perfect) as assessed by an investigator. | All participants received 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, approximately 1.5 hours.
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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 | All participants that wore Lens A | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose 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 11, 2022 | Oct 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D006956 | Hyperopia |
| 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 |
Soft spherical silicone hydrogel contact lens for 15 minutes |
|
| 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 |
|
|
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lens B | All participants that wore Lens B | 0 | 40 | 0 | 40 | 0 | 40 |
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