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The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens, then Control Lens | Experimental | Participants wore Test Lens for 2 days, and then Control Lens for 2 days |
|
| Control Lens, then Test Lens | Active Comparator | Participants wore Control Lens for 2 days, and then Test Lens for 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens | Device | Daily disposable with modified lens design for 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort With Lens | Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision Quality | Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision. | 2 days |
| Overall Lens Fit Acceptance | Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Optometry | Bloomington | Indiana | 47405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens, Then Control Lens | Participants wore Test Lens for 2 days (Period 1), and then Control Lens for 2 days (Period 2) |
| FG001 | Control Lens, Then Test Lens | Participants wore Control Lens for 2 days (Period 1), and then Test Lens for 2 days (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (2 Days) |
| |||||||||||||
| Period 2 (2 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All participants who were dispensed lenses and successfully completed the study |
| 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 | Overall Comfort With Lens | Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort. | Posted | Mean | Standard Deviation | score on a scale | 2 days |
|
Duration of the study, approximately 4 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 | Test Lens | Participants that received Test lens during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Hall BSc PhD MCOptom, FBCLA | CooperVision Inc. | 925-251-6884 | lhall@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 | May 21, 2021 | Jul 3, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Control Lens | Device | Daily disposable lens for 2 days |
|
| 2 days |
| Overall Lens Handling | Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling. | 2 days |
| Anterior Ocular Health - Corneal Staining Extent | Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately. | 2 days |
| NOT COMPLETED |
|
| 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 |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Overall Vision Quality | Participant response measured once after 2 days of wear on a 0-100 integer scale, where 0= Unacceptable, 100=Excellent Vision. | Posted | Mean | Standard Deviation | score on a scale | 2 days |
|
|
|
| Secondary | Overall Lens Fit Acceptance | Measured once after 2 days of wear by investigator on lens fit alone (excludes comfort, vision, orientation) on a 0-4 scale, 0.25 steps, where 0=Can't be worn and 4=Optimum | Posted | Mean | Standard Deviation | score on a scale | 2 days |
|
|
|
| Secondary | Overall Lens Handling | Participant response on overall handling (insertion, removal, and holding) of contact lenses assessed once after 2 days of wear, on the third day. Measured on a 0-100 integer scale, where 0=Cannot be managed, 100=Excellent handling. | Posted | Mean | Standard Deviation | score on a scale | 2 days |
|
|
|
| Secondary | Anterior Ocular Health - Corneal Staining Extent | Assessed once after 2 days of wear with slit lamp biomicroscopy and graded on a 0-4 integer scale, where 0=No Staining and 4=>45% of area. Lower values represented a better outcome, e.g., a grading value of 1 would represent less corneal staining than a grade of 4. Locations (central, nasal, temporal, superior, inferior) were graded separately. | Posted | Mean | Standard Deviation | score on a scale | 2 days |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Lens | Participants that received Control lens during either the first or second period of the study. | 0 | 35 | 0 | 35 | 0 | 35 |
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| Temporal |
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| Superior |
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| Inferior |
|