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The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.
This was a prospective, crossover, bilateral daily wear, and subject masked dispensing study. The habitual contact lenses were not optimized. There was no randomization of the study lenses, participants wore the control lenses for the first wear period and the test for the second wear period. Participants wore each study lens for 3-7 days and then attend a prescription optimization visit. After this optimization visit, they wore each study lens for a 2-week period. During the 2-week wear period, participants recorded their subjective lens-wear experience remotely.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Lens | Active Comparator | All subjects will wear control lenses for two weeks and then will wear Test lenses for two weeks. |
|
| Test Lens | Experimental | After wearing control lenses for two weeks, all subjects will wear test lenses for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control lenses | Device | Control Multifocal lenses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort on Insertion | Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses). | Day 1 after Lens Dispense Visit |
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Inclusion Criteria:
Is at least 42 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Self reports having a full eye examination in the previous two years;
Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week;
Is willing and able to follow instructions and maintain the appointment schedule;
Habitually wears multifocal soft contact lenses, for the past 3 months minimum;
Has refractive astigmatism no higher than -0.75DC;
Is presbyopic and requires a reading addition of at least +0.75D and no more than
+2.50D;
Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00DS)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones | University of Waterloo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coan EyeCare | Ocoee | Florida | 34761 | United States | ||
| Kannarr Eye care |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All subjects wore control lenses for two weeks and then wore Test lenses for two weeks. Control lenses: Control Multifocal lenses Test lenses: Test Multifocal lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control Lens |
|
| ||||||||||||||||||
| Test Lens |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All subjects wore control lenses for two weeks and then test lenses for two weeks. |
| 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 | Comfort on Insertion | Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses). | Posted | Mean | Standard Deviation | units on a scale | Day 1 after Lens Dispense Visit |
|
From dispense up to 2 weeks on each study lens, a total of 4 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 | Control Lens | All subjects wore control lenses for two weeks and then wore Test lenses for two weeks. Control lenses: Control Multifocal lenses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light Sensitivity | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega | CooperVision | 9256402964 | 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 26, 2021 | Mar 17, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Test lenses |
| Device |
Test Multifocal lenses |
|
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| Sacco Eye Group PLLC | Vestal | New York | 13850 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Nittany Eye Associates | College | Pennsylvania | 16801 | United States |
|
| 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 |
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 2 |
| 63 |
| EG001 | Test Lens | After wearing control lenses for two weeks, all subjects wore test lenses for two weeks. Test lenses: Test Multifocal lenses | 0 | 63 | 0 | 63 | 2 | 63 |
| Eye Irritation and Discomfort | Eye disorders | Systematic Assessment |
|
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