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This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the control lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comfilcon A lens (test) | Experimental | Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. |
|
| Omafilcon B Lens (control) | Active Comparator | Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comfilcon A lens (test) | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity is assessed for test and control lens on a logMAR chart | up to 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity | Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | up to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University | Bloomington | Indiana | 47405 | United States |
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Three subjects did not meet the inclusion criteria. Seventeen (17) subjects completed all visits and were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A Lens Then Omafilcon B Lens | Subjects are randomized to wear comfilcon A lens for up to 3 hours then omafilcon B lens for up to 3 hours during this cross over study. Comfilcon A lens (test): contact lens |
| FG001 | Omafilcon B Lens Then Comfilcon A | Subjects are randomized to wear omafilcon B lens for up to 3 hours then comfilcon A lens up to 3 hours during this cross over study. Omafilcon B lens (control): contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Intervention (3 Hours) |
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| 2nd Intervention (3 Hours) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Comfilcon A Lens (Test) and Omafilcon B (Control) | Subjects were randomized to wear the comfilcon A (test) or omafilcon B (control) lens for up to 3 hours, 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 is assessed for test and control lens on a logMAR chart | Posted | Mean | Standard Deviation | logMAR | up to 3 hours |
|
Up to 3 hours per intervention.
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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 Lens (Test) | Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study. Comfilcon A lens (test): contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen, Sr. Optometrist | CooperVision | 19257306716 | 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 9, 2018 | Jan 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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This will be, prospective, single-masked, randomized, bilateral, cross-over, non-dispensing study comparing the test lens against the control lens.
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| Omafilcon B lens (control) | Device | contact lens |
|
|
| Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity |
Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. |
| up to 3 hours |
| Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity | Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | up to 3 hours |
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| 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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| Units | Counts |
|---|
| Participants |
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| Secondary | Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity | Subjective assessment of visual performance for distance day-time navigation tasks for vision/clarity was assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | up to 3 hours |
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|
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| Secondary | Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity | Subjective assessments of visual performance for intermediate / computer tasks for vision quality and clarity were assessed for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | up to 3 hours |
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| Secondary | Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity | Subjective assessments of visual performance for near vision was assessed for vision quality and clarity for test and control lens at different testing distances. Scale 0-100, 0=poor, 100=excellent. | Posted | Mean | Standard Deviation | units on a scale | up to 3 hours |
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|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Omafilcon B Lens (Control) | Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study. Omafilcon B lens (control): contact lens | 0 | 17 | 0 | 17 | 0 | 17 |
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