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The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism.
The objective of the study was to compare the handling and performance of Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism. This is a prospective, randomized, participant masked, crossover, bilateral dispensing study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A then samfilcon A | Experimental | Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. |
|
| samfilcon A then comfilcon A | Active Comparator | Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | Subjects will be randomized to wear comfilcon A for one month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ease of Lens Handling at Insertion | Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy). | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD FCOptom | University of Waterloo | Principal Investigator |
| Fiona Soong | Eyes on Sheppard Clinic | Principal Investigator |
| Adam Keech | Oakley Eyecare | Principal Investigator |
| Howard Dolman | Dolman Eyecare Centre | Principal Investigator |
| Kristin Heeney | Spadina Optometry | Principal Investigator |
| Michael Kreuzer | Glasses Half Full | Principal Investigator |
| Shane Foster | Athens Eye Care | Principal Investigator |
| Michael Cymbor | Nittany Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens Eye care | Athens | Ohio | 45701 | United States | ||
| Nittany Eye Associates |
Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Then Samfilcon A | Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. comfilcon A: Subjects will be randomized to wear comfilcon A for one month. Samfilcon A: Subjects will be randomized to wear samfilcon A for one month. |
| FG001 | Samfilcon A Then Comfilcon A | Subjects were randomized to wear samfilcon A for one month then comfilcon A for one month in this randomized, bilateral cross-over study. comfilcon A: Subjects will be randomized to wear comfilcon A for one month. Samfilcon A: Subjects will be randomized to wear samfilcon A for one month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects were randomized to wear comfilcon A for one month then Samfilcon A for one month in this randomized, bilateral cross-over study. The baseline measures include information of all 64 eligible participants. Of the 64 eligible participants, 63 were dispensed with study products, and one participant withdrew after the screening visit due to lens handling and general time commitment concerns. |
| 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 | Ease of Lens Handling at Insertion | Subjective at-home ratings for ease of lens handling for insertion, using a 0-10 scale (0-Very difficult, 10 - Very easy). | Out of 58 subjects who completed the study, data of three participants from the comfilcon A Arm /group and data of two participants from samfilcon A Arm / group was excluded from the analysis due to minor protocol deviations. | Posted | Mean | Standard Deviation | score on a scale | Day 28 |
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One month on each study lenses, a total of two months.
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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 | Comfilcon A | Subjects were randomized to wear comfilcon A for one month in this randomized, bilateral cross-over study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| conjunctivitis | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, OD, MSc, FAAO | CooperVision, Inc | 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 | Dec 21, 2020 | Dec 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Samfilcon A | Device | Subjects will be randomized to wear samfilcon A for one month. |
|
|
| State College |
| Pennsylvania |
| 16801 |
| United States |
| Glasses Half Full | Edmonton | Alberta | T5N1S5 | Canada |
| Oakley Eyecare | Winnipeg | Manitoba | R2C 3B4 | Canada |
| Dolman Eyecare Centre | New Hamburg | Ontario | N3A 1K2 | Canada |
| Spadina Optometry | Toronto | Ontario | M5V 2K8 | Canada |
| Lyndon Jones | Waterloo | Ontorio | N2L 3G1 | Canada |
| NOT COMPLETED |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 9 |
| 61 |
| EG001 | Samfilcon A | Subjects were randomized to wear samfilcon A for one month in this randomized, bilateral cross-over study. | 0 | 63 | 0 | 63 | 9 | 63 |
| Infiltrative Keratitis | Eye disorders | Systematic Assessment |
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| Non-Ocular Event | General disorders | Systematic Assessment |
|
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