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This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study
The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A (habitual) | No Intervention | All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses. | |
| fanfilcon A | Active Comparator | All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fanfilcon A | Device | contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | High contrast distance visual acuity is measured by LogMAR. | baseline, 2 weeks, 1 month |
| Centration | Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable). | baseline, 2 weeks, 1 month |
| Corneal Coverage | Corneal coverage will be assessed (yes/no) | baseline, 2 weeks, 1 month |
| Post-blink Movement | Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable) | baseline, 2 weeks, 1 month |
| Fit Acceptability | Investigator fit acceptability for each lens pair. 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) | baseline, 2 weeks, 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 (5 days per week; > 8 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 frequently using rewetting/ lubricating eye drops (more than once per day)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Contact Lens Service | Miami | Florida | 33136 | United States | ||
| Debbie Kim |
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37 participants were initially enrolled (assigned a study ID), with 1 failing the screening. A total of 36 participants wore the control lens (enfilcon A toric) first and then refitted and dispensed the test lenses (fanfilcon A toric) at baseline visit. There were no discontinuations.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses) | All participants wore enfilcon A toric lens (habitual) and then wore fanfilcon A toric lenses for 1 month. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis was performed prior to one participant completing the 2 week and 1 month visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enfilcon A Toric / Fanfilcon A Toric | All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit. |
| 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 | High contrast distance visual acuity is measured by LogMAR. | Analysis was performed prior to one participant completing the 2 week and 1 month visits. | Posted | Mean | Standard Deviation | logMAR | baseline, 2 weeks, 1 month |
|
Adverse event data collected at all scheduled visits over a 1 month period of time
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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 | All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses) | All participants wore enfilcon A toric lenses (habitual) and then refitted with fanfilcon A toric lenses at baseline visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose Vega, O.D., MSc., FAAO | CooperVision | 9256213761 | JVega2@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2016 | Mar 13, 2018 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2016 | Mar 13, 2018 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Closter |
| New Jersey |
| 07624 |
| United States |
| West Village Eyecare | New York | New York | 10014 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| 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 | Count of Participants | Participants |
|
| OG002 |
| Fanfilcon A Toric (2 Weeks) |
All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit. |
| OG003 | Fanfilcon A Toric (1 Month) | All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit. |
|
|
| Primary | Centration | Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable). | Analysis was performed prior to one participant completing the 2 week and 1 month visits. | Posted | Count of Participants | Participants | baseline, 2 weeks, 1 month |
|
|
|
| Primary | Corneal Coverage | Corneal coverage will be assessed (yes/no) | Analysis was performed prior to one participant completing the 2 week and 1 month visits. | Posted | Count of Participants | Participants | baseline, 2 weeks, 1 month |
|
|
|
| Primary | Post-blink Movement | Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable) | Analysis was performed prior to one participant completing the 2 week and 1 month visits. | Posted | Mean | Standard Deviation | units on a scale | baseline, 2 weeks, 1 month |
|
|
|
| Primary | Fit Acceptability | Investigator fit acceptability for each lens pair. 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 was performed prior to one participant completing the 2 week and 1 month visits. | Posted | Mean | Standard Deviation | units on a scale | baseline, 2 weeks, 1 month |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.
| Acceptable |
|
| Unacceptable |
|
| No |
|