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The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.
This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| comfilcon A | Active Comparator | Participants are randomized to wear the comfilcon A lens for one month during the cross over study. |
|
| senofilcon C | Active Comparator | Participants are randomized to wear the senofilcon C lens for one month during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| comfilcon A | Device | contact lens |
| |
| senofilcon C |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Fit Acceptance | Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect. | Up to 1 month |
| Corneal Coverage | Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no) | Up to 1 month |
| Lens Centration | Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable) | Up to 1 month |
| Post-blink Movement | Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement) | Up to 1 month |
| Lens Lag at Primary Gaze | Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size) | Up to 1 month |
| Tightness on Push up | Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement) | Up to 1 month |
| Lens Wettability | Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent) | Up to 1 month |
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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:
Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Is habitually using rewetting/ lubricating eye drops more than once per day
Is currently wearing daily disposable lenses
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| Name | Affiliation | Role |
|---|---|---|
| Lyndon Jones, PhD, FAAO, FIACLE, FBCLA | Centre for Contact Lens Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden Optometric Group | Whittier | California | 90606 | United States | ||
| Coan Eye Care & Optical Boutique |
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There were 88 participants enrolled for this study, with 1 participant failed the screening leading to 87 who were fitted with and dispensed contact lenses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfilcon A First Then Senofilcon C | Participants randomized to wear the comfilcon A lens first then crossover to Senofilcon C |
| FG001 | Senofilcon C First Then Comfilcon A | Participants randomized to wear the senofilcon C lens first then crossover to comfilcon A |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention : 1 Month |
|
| |||||||||||||||||||||
| Second Intervention: 1 Month |
|
Entire Study Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Baseline Characteristics | Includes groups randomized to wear comfilcon A lens first and senofilcon C lens first. |
| 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 | Overall Lens Fit Acceptance | Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect. | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 month |
|
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Assessment of adverse events was performed during the study visits. Investigators may be notified of adverse events by the participants outside of the study visits.
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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 | Participants are randomized to wear the comfilcon A lens for one month during either as the first or second intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Motocycle Accident | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr.Manager Global Medical Scientific Affairs | CooperVision Inc | (925) 621-3761 | javega@coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Device |
contact lens |
|
| Deposit Grading | Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits) | Up to 1 month |
| Ocoee |
| Florida |
| 34761 |
| United States |
| Cornea & Contact Lens Institute of Minnesota | Edina | Minnesota | 55436 | United States |
| Sacco Eye Group | Vestal | New York | 13850 | United States |
| Vision Professionals | New Albany | Ohio | 43054 | United States |
| Adverse Event |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention.
comfilcon A: contact lens
| OG002 | Comfilcon A After 1 Month | Participants are randomized to wear the comfilcon A lens for one month either as the first or second intervention. comfilcon A: contact lens |
| OG003 | Senofilcon C at Dispense | Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens |
| OG004 | Senofilcon C After 2 Weeks | Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens |
| OG005 | Senofilcon C After 1 Month | Participants are randomized to wear the senofilcon C lens for one month either as the first or second intervention. senofilcon C: contact lens |
|
|
| Primary | Corneal Coverage | Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Number | participants | Up to 1 month |
|
|
|
| Primary | Lens Centration | Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Number | participants | Up to 1 month |
|
|
|
| Primary | Post-blink Movement | Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 month |
|
|
|
| Primary | Lens Lag at Primary Gaze | Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Mean | Standard Deviation | millimeters | Up to 1 month |
|
|
|
| Primary | Tightness on Push up | Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 month |
|
|
|
| Primary | Lens Wettability | Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 month |
|
|
|
| Primary | Deposit Grading | Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits) | Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 1 month |
|
|
|
| 1 |
| 87 |
| 0 |
| 87 |
| EG001 | Senofilcon C | Participants are randomized to wear the senofilcon C lens for one month during either as the first or second intervention. | 0 | 83 | 0 | 83 |
Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
| No |
|
| Acceptable |
|
| Unacceptable |
|