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This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.
This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A | Experimental | Participants wore Lens A for 15 minutes (Period 1) |
|
| Lens B | Experimental | Participants wore Lens B for 15 minutes (Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A | Device | Hydrogel Daily Disposable Toric Contact Lens for 15 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Handling at Insertion, Dispensing Visit | Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear. | 15 minutes |
| Subjecting Handling at Insertion, Follow-up Visit | Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear. | 15 minutes |
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Inclusion Criteria:
A person was eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person was excluded from the study if he/she:
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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 |
|---|---|---|---|---|---|---|
| Clinic of Optometry; Faculty of Optics and Optometry | Madrid | 28037 | Spain |
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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 study participants that 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 | Age was stratified by sex (Male and Female) |
| 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 at Insertion, Dispensing Visit | Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
Duration of the study, approximately 2 days
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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, PhD, FAAO | CooperVision Inc. | +19256213761 | 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 | Nov 29, 2022 | Nov 12, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B |
| Device |
Silicone Hydrogel Daily Disposable Toric Contact Lens for 15 minutes |
|
| NOT COMPLETED |
|
| Mean |
| Standard Deviation |
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Subjecting Handling at Insertion, Follow-up Visit | Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear. | Posted | Mean | Standard Deviation | score on a scale | 15 minutes |
|
|
|
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lens B | Participants that received Lens B | 0 | 40 | 0 | 40 | 0 | 40 |
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