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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 13-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A Extended Range test lens | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. | 4 days |
| Visual Performance | Subjective assessment of visual performance for test and control lens is assessed on a 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 |
|---|---|---|
| Subjective Ratings for Comfort | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | Baseline |
| Subjective Ratings for Comfort |
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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 |
|---|---|---|
| Pete S Kollbaum, O.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CORL, Indiana University | Bloomington | Indiana | 47405 | 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 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 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 first as per the randomization table bilaterally for four days then cross-over to alternated pair lenses. comfilcon A Extended Range test lens: contact lenses comfilcon A control lens: contact lenses |
| 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 | Visual Acuity | Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. | Posted | Mean | Standard Deviation | LogMAR | 4 days |
|
From dispense up to four days on each pair of contact 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 lens |
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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 lens |
|
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
| 4 days |
| Subjective Ratings for Dryness | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | Baseline |
| Subjective Ratings for Dryness | Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). | 4 days |
| Lens Handling | Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). | 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 grading system in 0.25 steps where 0 represented very poor fit. | 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 |
| Subjective Satisfaction | Subjective satisfaction for test and control lens was assessed on a 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. comfort, vision, handling, satisfaction. | 4 days |
| Subjective Preference for Distance Vision | Subjective preference for distance 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 Overall Vision | Subjective preference for overall vision for test and control contact lenses. | 4 days |
| Subjective Preference for Comfort | Subjective preference for comfort for test and control contact lenses. | 4 days |
| Subjective Overall Lens Preference | Subjective overall lens preference for test and control contact lenses. | 4 days |
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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 |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Visual Performance | Subjective assessment of visual performance for test and control lens is assessed on a 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 | Subjective Ratings for Comfort | Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Secondary | Subjective Ratings for Comfort | Subjective ratings for comfort was assessed for test and control lens on a 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 | Subjective Ratings for Dryness | Subjective ratings for dryness was assessed for test and control lens on a 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 | Subjective Ratings for Dryness | Subjective ratings for dryness was assessed for test and control lens on a 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 | Lens Handling | Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). | Posted | Mean | Standard Deviation | units on a scale | 4 Days |
|
|
|
| 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 grading system in 0.25 steps where 0 represented very poor fit. | 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 |
|
|
|
| Secondary | Subjective Satisfaction | Subjective satisfaction for test and control lens was assessed on a 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. comfort, vision, handling, satisfaction. | Posted | Count of Participants | Participants | 4 days |
|
|
|
| Secondary | Subjective Preference for Distance Vision | Subjective preference for distance vision for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
|
|
|
| Secondary | Subjective Preference for Intermediate Vision | Subjective preference for intermediate vision for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
|
|
|
| Secondary | Subjective Preference for Overall Vision | Subjective preference for overall vision for test and control contact lenses. | Posted | Count of Participants | Participants | 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 Overall Lens Preference | Subjective overall lens preference for test and control contact lenses. | Posted | Count of Participants | Participants | 4 days |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| 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 lens | 0 | 13 | 0 | 13 | 0 | 13 |
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| Near |
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