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| Name | Class |
|---|---|
| Centre for Ocular Research & Education, Canada | OTHER |
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The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens, then Test Lens | Experimental | Participants wore the Control Lens for 90 minutes, then the Test Lens for 90 minutes. |
|
| Test Lens, then Control Lens | Experimental | Participants wore the Test Lens for 90 minutes, then the Control Lens for 90 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Lens | Device | Daily disposable contact lens for 90 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lens Handling at Insertion | Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult. | Immediately after lens application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FCOptom | Centre for Ocular Research and Education (CORE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo School of Optometry & Vision Science | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Lens, Then Test Lens | Participants wore the Control Lens for 90 minutes (Period 1), and then the Test Lens for 90 minutes (Period 2) |
| FG001 | Test Lens, Then Control Lens | Participants wore the Test Lens for 90 minutes (Period 1), and then the Control Lens for 90 minutes (Period 2) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: First Intervention-90 Minutes |
| |||||||||||||
| Period 2: Second Intervention-90 Minutes |
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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 | Lens Handling at Insertion | Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult. | Posted | Mean | Standard Deviation | score on a scale | Immediately after lens application |
|
Duration of the study, approximately 4 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 | Control Lens | Participants that received Control lens during either the first or second period of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lee Hall | CooperVision, Inc. | +19252516684 | 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 | Jun 20, 2023 | Nov 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Test Lens | Device | Monthly replacement contact lens for 90 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 |
|
| Units | Counts |
|---|---|
| Participants |
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Test Lens | Participants that received Test lens during either the first or second period of the study. | 0 | 30 | 0 | 30 | 0 | 30 |
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