Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to evaluate and compare the performance of verofilcon A to somofilcon A 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 somofilcon A (test lens) and verofilcon A (control lens).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somofilcon A | Experimental | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week. |
|
| verofilcon A | Active Comparator | Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somofilcon A | Device | Subjects will be randomized to wear somofilcon A daily disposable lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Ratings for Lens Handling for Lens Insertion | Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy). | 1 week |
| Subjective Ratings for Lens Handling for Lens Removal | Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Fit - Centration | Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus) | Baseline |
| Lens Fit - Centration |
Not provided
Inclusion Criteria:
-
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
-
A person may be excluded from the study if he/she:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Somofilcon A Then Verofilcon A | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week and then switch to verofilcon A daily disposable lenses for one week. |
| FG001 | Verofilcon A the Somofilcon A | Subjects will be randomized to wear verofilcon A daily disposable lenses for one week and then switch to somofilcon A daily disposable lenses for one week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects will be randomized to wear somofilcon A daily disposable lenses and verofilcon A daily disposable lenses for one week. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Subjective Ratings for Lens Handling for Lens Insertion | Subjective ratings for Lens handling for lens insertion (0 - 10 integer scale), (0- very difficult, 10- very easy). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
From dispense to 1 week on each lens, a total of two weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Somofilcon A | Subjects will be randomized to wear somofilcon A daily disposable lenses for one week. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperemia | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, OD, MSc, FAAO | CooperVision, Inc | 9256213761 | JVega2@coopervision.com |
Not provided
| 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 | Dec 16, 2020 | Nov 30, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| verofilcon A | Device | Subjects will be randomized to wear verofilcon A daily disposable lenses. |
|
|
Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus)
| 1-week |
| Lens Fit - 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 |
| Lens Fit - 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 |
| Lens Fit - Lens Push-up Tightness | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement | Baseline |
| Lens Fit - Lens Push-up Tightness | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement | 1-week |
| NOT COMPLETED |
|
|
| Participants |
|
| Age, Continuous | 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 |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Subjective Ratings for Lens Handling for Lens Removal | Subjective ratings for Lens handling for lens removal (0 - 10 integer scale), (0-very difficult, 10- very easy). | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Lens Fit - Centration | Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Lens Fit - Centration | Lens Fit Centration was measured on a scale of 0-3 (0-optimal, 1-slight decentration, 2-moderate decentration but not encroaching limbus, 3- excessive & occasionally encroaching limbus) | One subject missed follow-up assessment for lens-fit centration. | Posted | Mean | Standard Deviation | units on a scale | 1-week |
|
|
|
| Secondary | Lens Fit - 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 | Lens Fit - 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 | Lens Fit - Lens Push-up Tightness | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Lens Fit - Lens Push-up Tightness | The lens push-up tightness was graded using a 0 - 100 scale (5% steps) where 0% = falls from cornea without lid support, 50% = optimum and 100% = no movement | Posted | Mean | Standard Deviation | units on a scale | 1-week |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 2 |
| 51 |
| EG001 | Verofilcon A | Subjects will be randomized to wear verofilcon A daily disposable lenses for one week. | 0 | 51 | 0 | 51 | 1 | 51 |
| Mild Ocular Redness | Eye disorders | Systematic Assessment |
|
| Headache | Eye disorders | Systematic Assessment |
|
Not provided
Not provided