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The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A Extended Range test lens | Experimental | Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
|
| comfilcon A control lens | Active Comparator | Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A Extended Range test lens | Device | contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR. | 4 days |
| Visual Performance | Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). | 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | Baseline |
| Comfort | Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
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Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
Exclusion Criteria:
A person will be excluded from the study if he/she:
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| Name | Affiliation | Role |
|---|---|---|
| Meng C Lin, PhD | CRC, UC Berkeley | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, University of California, Berkeley | Berkeley | California | 94704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens Then Control Lens | Subjects will be randomized to wear the test contact lenses first then control contact lenses bilaterally for four days in the cross-over study. comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses |
| FG001 | Control Lens Then Test Lens | Subjects will be randomized to wear the control contact lenses first then test contact lenses bilaterally for four days in the cross-over study. comfilcon A control lens: contact lenses comfilcon A Extended Range test lens: contact lenses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Subjects will be randomized to wear the test contact lenses or control contact lenses bilaterally first for four days then cross-over to alternate study lenses. comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses |
| 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 | Visual Acuity | Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR. | Posted | Mean | Standard Deviation | LogMAR | 4 days |
|
From dispense up to 4 days on each pair of lenses.
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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 Extended Range Test Lens | Subjects will be randomized to wear the test contact lenses bilaterally for four days in this cross-over study. comfilcon A Extended Range test lens: contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Myhanh Nguyen | CooperVision, Inc. | 925-730-6716 | mnguyen@coopervision.com |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| comfilcon A control lens | Device | contact lenses |
|
| 4 days |
| Dryness | Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | Baseline |
| Dryness | Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | 4 days |
| Subjective Preference for Comfort | Subjective preference for comfort for test and control contact lenses. | 4 days |
| Subjective Satisfaction | Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied) | 4 days |
| Subjective Preference for Near Vision | Subjective preference for Near Vision for test and control contact lenses. | 4 days |
| Subjective Preference for Intermediate Vision | Subjective preference for intermediate vision for test and control contact lenses. | 4 days |
| Subjective Preference for Distance Vision | Subjective preference for distance vision for test and control contact lenses. | 4 days |
| Subjective Overall Vision Preference | Subjective overall vision preference for test and control contact lenses. | 4 days |
| Average Daily Wearing Time | Average daily wearing time for test and control lens is assessed in hours. | 4 days |
| Lens Fit | Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit. | 4 days |
| Lens Handling | Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle). | 4 Days |
| Bulbar Hyperemia | Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia | 4 days |
| Limbal Hyperemia | Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia | 4 days |
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| Participants |
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| 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 |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Visual Performance | Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Comfort | Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Comfort | Subjective ratings for comfort was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Dryness | Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Dryness | Subjective ratings for dryness was assessed on a scale of 0-100 (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Subjective Preference for Comfort | Subjective preference for comfort for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
|
|
|
| Secondary | Subjective Satisfaction | Subjective satisfaction for test and control lens. Scale 0-100, 0=extremely dissatisfied, 100=very satisfied) | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Subjective Preference for Near Vision | Subjective preference for Near Vision for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
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|
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| Secondary | Subjective Preference for Intermediate Vision | Subjective preference for intermediate vision for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
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|
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| Secondary | Subjective Preference for Distance Vision | Subjective preference for distance vision for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
|
|
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| Secondary | Subjective Overall Vision Preference | Subjective overall vision preference for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
|
|
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| Secondary | Average Daily Wearing Time | Average daily wearing time for test and control lens is assessed in hours. | Posted | Mean | Standard Deviation | Hours/Day | 4 days |
|
|
|
| Secondary | Lens Fit | Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 scale in 0.25 steps 0- very poor fit. | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Lens Handling | Subjective ratings for handling (ease of insertion and removal) was assessed on a Scale of 0-100 (0=very difficult to handle, 100=easy to handle). | Posted | Mean | Standard Deviation | units on a scale | 4 Days |
|
|
|
| Secondary | Bulbar Hyperemia | Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| Secondary | Limbal Hyperemia | Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia | Posted | Mean | Standard Deviation | units on a scale | 4 days |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Comfilcon A Control Lens | Subjects will be randomized to wear the control contact lenses bilaterally for four days in this cross-over study. comfilcon A control lens: contact lenses | 0 | 12 | 0 | 12 | 0 | 12 |
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| Near |
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