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This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Multifocal Toric Lens | Experimental | comfilcon A multifocal toric lens |
|
| omafilcon A Multifocal Toric Lens | Active Comparator | Control multifocal toric lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A multifocal toric lens | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual Acuity (measured in LogMAR) | Up to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity | Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Up to 2 hours |
| Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Morgan, BSc, PhD, MCOptom | Eurolens Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurolens Research | Manchester | M13 9PL | United Kingdom |
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Three subjects did not meet the inclusion criteria. Ten (10) subjects completed all visits and their data were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Multifocal Toric Lens Then Control Multifocal Toric | Subjects were randomized to wear the test multifocal toric lens then control multifocal toric lens during this crossover study. comfilcon A multifocal toric lens: contact lens |
| FG001 | Control Multifocal Toric Lens Then Test Multifocal Toric | Subjects were randomized to wear the control multifocal toric lens then test multifocal toric lens during this crossover study. omafilcon A Multifocal Toric Lens: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A and Omafilcon A Multifocal Toric Lenses | Subjects were randomized to wear the comfilcon A multifocal toric (test) or omafilcon A multifocal toric (control) lens, either as first or second lens during this cross over study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Acuity | Visual Acuity (measured in LogMAR) | Posted | Mean | Standard Deviation | logMAR | Up to 2 hours |
|
Up to 2 hours
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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 Multifocal Toric Lens | Subjects were randomized to wear the comfilcon A multifocal toric lens, either as first or second lens during this crossover study. comfilcon A multifocal toric lens: contact lens omafilcon A Multifocal Toric Lens: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen, Sr. Optometrist | CooperVision | 925-730-6716 | MNguyen@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 | Feb 21, 2018 | Jan 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| omafilcon A Multifocal Toric Lens | Device | contact lens |
|
|
Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. |
| Up to 2 hours |
| Assessment of Visual Performance: Near Task for Vision Quality and Clarity | Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Up to 2 hours |
| NOT COMPLETED |
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| 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 |
|
|
| Secondary | Assessment of Visual Performance: Distance Navigation Tasks for Vision Quality and Clarity | Subjective assessment of visual performance for distance navigation tasks for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | Up to 2 hours |
|
|
|
| Secondary | Assessment of Visual Performance: Intermediate Task for Vision Quality and Clarity | Subjective assessment of visual performance for intermediate task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | Up to 2 hours |
|
|
|
| Secondary | Assessment of Visual Performance: Near Task for Vision Quality and Clarity | Subjective assessment of visual performance for near task for vision quality and clarity was assessed on a scale 0-100, 0=poor, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | Up to 2 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Omafilcon A Multifocal Toric Lens | Subjects were randomized to wear the omafilcon A Multifocal Toric Lens, either as first or second lens during this crossover study. Control multifocal toric lens comfilcon A multifocal toric lens: contact lens omafilcon A Multifocal Toric Lens: contact lens | 0 | 10 | 0 | 10 | 0 | 10 |
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