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The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B.
The objective of the study was to compare the lens handling and performance of Lens A to habitually worn multifocal contact lenses and to the competitor Lens B. This was a prospective, randomized, participant-masked, crossover, bilateral dispensing study conducted at up to 5 clinical practice sites in the United States. Subjects were dispensed their habitual lenses for two weeks prior to randomization of Test Lens and Control Lens. Each lens type will be worn for 2 weeks after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A (Test) | Experimental | Subjects will be randomized to wear Lens A (test) the control Lens B for 2 weeks in this randomized, cross-over bilateral dispensing study. |
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| Lens B (Control) | Active Comparator | Subjects will be randomized to wear Lens B (control) and Lens A (Test) for 2 weeks in this randomized, cross-over bilateral dispensing study. |
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| Habitual Lenses | Active Comparator | All subjects will wear their habitual lenses for two weeks prior to randomization of Test lens A and control lens B. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A | Device | Subjects will be randomized to wear Lens A (test) for 2 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective At-home Ratings for Ease of Lens Handling for Insertion | Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy) | Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne Golden | Golden Vision | Principal Investigator |
| Keith Wan | Scripps Poway Eyecare | Principal Investigator |
| Shane Kannarr | Kannarr Eye Care | Principal Investigator |
| David Ardaya | Golden Optometric Group | Principal Investigator |
| Katherine Bickle | ProCare Vision Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Poway Eyecare | San Diego | California | 92131 | United States | ||
| Golden Optometric Group |
All 59 subjects wore their habitual lenses for two weeks prior to randomization to test lens and control lens.
60 subjects were enrolled and 1 subject discontinued because of screen failure prior to dispense of their habitual lenses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lens A (Test) Then Lens B (Control) | Subjects wore their habitual lenses for 2 weeks and were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact lens: Habitual Lenses Contact Lens: Test Lens A Contact Lens: Control Lens B |
| FG001 | Lens B (Control) Then Lens A (Test) | All Subjects wore their habitual lenses for 2 weeks prior to randomization and were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact Lens: Habitual lenses Contact lens: Control Lens B Contact Lens : Test lens A |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects wore their habitual lenses for two weeks and then randomized to wear Test lens A and Control Lens B for 2 weeks. |
| 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 | Subjective At-home Ratings for Ease of Lens Handling for Insertion | Subjective at-home ratings for ease of Lens handling for insertion will be assessed using a 0-10 scale, (0=very difficult, 10=very easy) | One subject was not included in the analysis for all study arms because of protocol deviation. One more subject was excluded form the analysis from Len B control Arm only. | Posted | Mean | Standard Deviation | units on a scale | Day 13 |
|
All subjects wore their habitual lenses for two weeks and then randomized to wear test lens A and control lens B for 2 weeks, a total of 6 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 | Subjects Habitual Lenses | All Subjects wore their habitual lenses for 2 weeks prior to randomization of test lens and control lens. Contact Lenses: Habitual Lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, OD, MSc, FAAO | CooperVision, Inc | 9256402964 | javega2@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 5, 2020 | May 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens B | Device | Subjects will be randomized to wear Lens B (control) for 2 weeks. |
|
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| Habitual Lenses | Device | All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens. |
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| Whittier |
| California |
| 90606 |
| United States |
| Golden Vision | Sarasota | Florida | 34237 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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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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Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study.
Contact Lens: Test Lens A
| OG002 | Lens B (Control) | Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact lens: Control Lens B |
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Lens A (Test) | Subjects were randomized to wear Lens A (test) then Lens B (control) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact Lens: Test Lens A | 0 | 59 | 0 | 59 | 0 | 59 |
| EG002 | Lens B (Control) | Subjects were randomized to wear Lens B (control) then Lens A (test) for 2 weeks in this randomized, cross-over bilateral dispensing study. Contact lens: Control Lens B | 0 | 59 | 0 | 59 | 0 | 59 |
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