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The aim of this prospective study is to evaluate the clinical performance of fanfilcon A toric and lotrafilcon B toric contact lenses after 1 month of wear in each pair.
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric (fanfilcon A) and AIR OPTIX for Astigmatism (lotrafilcon B) contact lenses after 1 month of wear in each pair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fanfilcon A toric | Experimental | Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study. |
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| lotrafilcon B | Active Comparator | Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fanfilcon A toric lens | Device | Contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Baseline |
| Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Dispense |
| Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | 1 Month |
| Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Baseline |
| Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Dispense |
| Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | 1 Month |
| Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | Baseline |
| Post-blink Movement |
| Measure | Description | Time Frame |
|---|---|---|
| Average Hours of Wear Per Day | Number of hours lenses are worn per day | Baseline |
| Average Hours of Wear Per Day | Number of hours lenses are worn per day |
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Inclusion Criteria:
Exclusion Criteria:
A person will be excluded from the study if he/she:
Has a CL prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic, National Autonomous University | Mexico City | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fanfilcon A Toric, Then Lotrafilcon B Toric | Subjects wore fanfilcon A toric contact lens for 1 month, then lotrafilcon B toric contact lens. Fanfilcon A toric: contact lens Lotrafilcon B toric: contact lens |
| FG001 | Lotrafilcon B Toric, Then Fanfilcon A Toric | Subjects wore lotrafilcon B toric contact lens for 1 month, then fanfilcon A toric contact lens. Lotrafilcon B toric: Contact lens Fanfilcon A toric: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Month) |
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| Second Intervention (1 Month) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fanfilcon A Toric vs. Lotrafilcon B Toric Contact Lens | Each subject is randomized to wear either the fanfilcon A toric or lotrafilcon B toric contact lens as a matched pair and crossed over to second matched pair. |
| 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 | Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Posted | Count of Participants | Participants | Baseline |
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From dispense to completion of follow up, up to 1 month.
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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 | Fanfilcon A Toric | Subjects who wore fanfilcon A toric contact lens, either as the first or second lens in this cross-over study. Fanfilcon A toric lens: Contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jose A. Vega, O.D., MSc., FAAO | CooperVision | 19256213761 | jvega2@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 | Oct 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lotrafilcon B toric lens | Device | Contact lens |
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Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) |
| Dispense |
| Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | 1 Month |
| Overall Fit Acceptance | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) | Dispense |
| Overall Fit Acceptance | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) | 1 Month |
| 1 month |
| Average Comfortable Wearing Time | Typical time of day when subject first experiences lens awareness or irritation. | Baseline |
| Average Comfortable Wearing Time | Typical time of day when subject first experiences lens awareness or irritation | 1 Month |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Posted | Count of Participants | Participants | Dispense |
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| Primary | Lens Centration | Centration of lens on eye in primary gaze (1-3 scale; 1=optimal centration, 2=Decentration acceptable, slightly, 3 = decentration unacceptable) | Posted | Count of Participants | Participants | 1 Month |
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| Primary | Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Posted | Count of Participants | Participants | Baseline |
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| Primary | Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Posted | Count of Participants | Participants | Dispense |
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| Primary | Corneal Coverage | Evaluate corneal coverage of contact lens (Yes=Full, No=Incomplete) | Posted | Count of Participants | Participants | 1 Month |
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| Primary | Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
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| Primary | Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | Posted | Mean | Standard Deviation | score on a scale | Dispense |
|
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| Primary | Post-blink Movement | Amount of lens movement after blink (0-4 scale, 0=insufficient, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement 4=excessive, unacceptable movement) | Posted | Mean | Standard Deviation | score on a scale | 1 Month |
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| Primary | Overall Fit Acceptance | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) | Posted | Mean | Standard Deviation | units on a scale | Dispense |
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| Primary | Overall Fit Acceptance | Assessed by investigator based on lens fit alone (0-4 scale; 0=should not be worn, 4=perfect) | Posted | Mean | Standard Deviation | units on a scale | 1 Month |
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| Secondary | Average Hours of Wear Per Day | Number of hours lenses are worn per day | Posted | Mean | Standard Deviation | hours per day | Baseline |
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| Secondary | Average Hours of Wear Per Day | Number of hours lenses are worn per day | Posted | Mean | Standard Deviation | hours per day | 1 month |
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| Secondary | Average Comfortable Wearing Time | Typical time of day when subject first experiences lens awareness or irritation. | Posted | Mean | Standard Deviation | hours per day | Baseline |
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| Secondary | Average Comfortable Wearing Time | Typical time of day when subject first experiences lens awareness or irritation | Posted | Mean | Standard Deviation | hours per day | 1 Month |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Lotrafilcon B Toric | Subjects who wore lotrafilcon B toric contact lens, either as the first or second lens in this cross-over study. Lotrafilcon B toric lens: Contact lens | 0 | 42 | 0 | 42 | 0 | 42 |
Investigator cannot publish / present data without prior consent from CooperVision.
| 3-Decentranation Unacceptable |
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| 3-Decentranation Unacceptable |
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