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The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates the study test lens and control lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Contact lens | Experimental | Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. |
|
| Control Contact Lens | Active Comparator | Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Contact Lens | Device | Subjects will be randomized to wear test lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Fit Acceptance | Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect) | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration | Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus") | Baseline |
| Lens Centration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FCOptom | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo | Waterloo | Ontario | N2L 3G1 | Canada |
Forty-one subjects were screened and 35 subjects started and completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Contact Lens the Control Contact Lens | Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. Test Contact Lens: Subjects will be randomized to wear test lenses. Control Contact Lens: Subjects will be randomized to wear control lenses. |
| FG001 | Control Contact Lens Then Test Contact Lens | Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. Test Contact Lens: Subjects will be randomized to wear test lenses. Control Contact Lens: Subjects will be randomized to wear control lenses. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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Forty-one subjects were screened and demographic data includes all screened subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects will be randomized to wear control lenses and test lenses for one week. Contact lenses: Test Contact Lens Contact lenses: Control Contact Lens |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Lens Fit Acceptance | Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
From dispense up to 1 week for a total of 2 weeks
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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 Contact Lens | Subjects will be randomized to wear test lenses for one week and then switch to control lenses for one week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc, FAAO | Coopervision | 9256213761 | 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 | May 20, 2020 | May 26, 2021 | 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 Contact Lens | Device | Subjects will be randomized to wear control lenses. |
|
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Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus")
| 1 week |
| Post-blink Movement | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps | Baseline |
| Post-blink Movement | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps | 1 week |
| Push-up Tightness | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Baseline |
| Push-up Tightness | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement) | 1 week |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Lens Centration | Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus") | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
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| Secondary | Lens Centration | Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive & occasionally encroaching limbus") | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Post-blink Movement | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps | Posted | Mean | Standard Deviation | mm | Baseline |
|
|
|
| Secondary | Post-blink Movement | Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps | Posted | Mean | Standard Deviation | mm | 1 week |
|
|
|
| Secondary | Push-up Tightness | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Push-up Tightness | Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement) | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Control Contact Lens | Subjects will be randomized to wear control lenses for one week and then switch to test lenses for one week. | 0 | 35 | 0 | 35 | 0 | 35 |
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