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The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.
This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stenfilcon A / Test lens | Experimental | All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test lens | Device | contact lens |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Lens Fit Acceptance | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) | Baseline (After 10 minutes of lens dispense) |
| Overall Lens Fit Acceptance | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) | 1 week on each study lenses |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration | Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable) | Baseline - After 10 minutes of lens dispense |
| Lens Centration |
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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:
Is participating in any concurrent clinical research study
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has a systemic condition that, in the opinion of the investigator, may affect the study measures
Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone refractive surgery.
Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
Has participated in any other type of eye related clinical or research study within the last 7 days
Is habitually using rewetting/ lubricating eye drops (more than once per day)
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| Name | Affiliation | Role |
|---|---|---|
| David Ardaya | Golden Optometric Group, CA | Principal Investigator |
| Shane Kannarr | Kannarr Eye Care, KS | Principal Investigator |
| Michael Cymbor | Nittany Eye Associates, PA | Principal Investigator |
| Wayne Golden | Golden Vision, FL | Principal Investigator |
| Eric M. White | CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eric White, O.D., Inc. | San Diego | California | 92123 | United States | ||
| Golden Optometric Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Test lens: contact lens control lens: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Test lens: contact lens control lens: contact lens |
| 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 | Overall Lens Fit Acceptance | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) | Posted | Mean | Standard Deviation | units on a scale | Baseline (After 10 minutes of lens dispense) |
|
From dispense up to 1 week on each study lenses, a total of 2 weeks.
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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 | Stenfilcon A Test Lens | All subjects will first wear stenfilcon A test contact lenses for one week. stenfilcon A test lens: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega | CooperVision, Inc | 925-640-2964 | javega2@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 | Jan 16, 2018 | Dec 21, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| control lens | Device | contact lens |
|
|
Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
| 1 week on each study lenses |
| Post-blink Movement | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) | Baseline (after 10 minutes of lens dispense) |
| Post-blink Movement | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) | 1 week on each study lenses |
| Whittier |
| California |
| 90606 |
| United States |
| Golden Vision | Sarasota | Florida | 34232 | United States |
| Nittany Eye Associates | State College | Pennsylvania | 16801 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
|
| Primary | Overall Lens Fit Acceptance | Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect) | Posted | Mean | Standard Deviation | units on a scale | 1 week on each study lenses |
|
|
|
| Secondary | Lens Centration | Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable) | Posted | Count of Participants | Participants | Baseline - After 10 minutes of lens dispense |
|
|
|
| Secondary | Lens Centration | Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable) | Posted | Count of Participants | Participants | 1 week on each study lenses |
|
|
|
| Secondary | Post-blink Movement | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) | Posted | Mean | Standard Deviation | units on a scale | Baseline (after 10 minutes of lens dispense) |
|
|
|
| Secondary | Post-blink Movement | Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive) | Posted | Mean | Standard Deviation | units on a scale | 1 week on each study lenses |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Stenfilcon A Control Lens | All subjects will first wear stenfilcon A control contact lenses for one week. stenfilcon A control lens: contact lens | 0 | 77 | 0 | 77 | 0 | 77 |
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| Unacceptable |
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| Unacceptable |
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