Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
Primary Purpose
Astigmatism
Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
somofilcon A toric contact lens
fanfilcon A toric contact lens
Sponsored by
About this trial
This is an interventional other trial for Astigmatism
Eligibility Criteria
Inclusion Criteria:
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)
- Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria:
- 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:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- 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.
Sites / Locations
- Optometry Clinic, National Autonomous University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
somofilcon A toric (habitual), then fanfilcon toric (test)
Arm Description
Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.
Outcomes
Primary Outcome Measures
Lens Centration - Somofilcon A Toric (Habitual) Lens
Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Somofilcon A Toric (Habitual) Lens
Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Fanfilcon A Toric Lens
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Fanfilcon A Toric Lens
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Fanfilcon A Toric Lens
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Fanfilcon A Toric Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Fanfilcon A Toric Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Fanfilcon A Toric Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-Blink Movement - Fanfilcon A Toric Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-Blink Movement - Fanfilcon A Toric Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-Blink Movement - Fanfilcon A Toric Lens
Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Secondary Outcome Measures
Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens
Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.
Average Daily Wearing Time - Fanfilcon A Toric Lens
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Average Daily Wearing Time - Fanfilcon A Toric Lens
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens
Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04050605
Brief Title
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
Official Title
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
Detailed Description
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Astigmatism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.
Masking
None (Open Label)
Masking Description
Study lenses will be transferred, by an assistant, out of their packaging to unmarked new contact lens cases filled with preservative free sterile saline just prior to dispensing to maintain subject masking of the study lenses.
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
somofilcon A toric (habitual), then fanfilcon toric (test)
Arm Type
Experimental
Arm Description
Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens.
Intervention Type
Device
Intervention Name(s)
somofilcon A toric contact lens
Other Intervention Name(s)
Habitual lens
Intervention Description
Contact Lens
Intervention Type
Device
Intervention Name(s)
fanfilcon A toric contact lens
Other Intervention Name(s)
Test Lens
Intervention Description
Contact Lens
Primary Outcome Measure Information:
Title
Lens Centration - Somofilcon A Toric (Habitual) Lens
Description
Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Lens Centration - Somofilcon A Toric (Habitual) Lens
Description
Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4 weeks
Title
Lens Centration - Fanfilcon A Toric Lens
Description
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
Baseline
Title
Lens Centration - Fanfilcon A Toric Lens
Description
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
2-weeks
Title
Lens Centration - Fanfilcon A Toric Lens
Description
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Time Frame
4-weeks
Title
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Description
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
Baseline
Title
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Description
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
4-weeks
Title
Corneal Coverage - Fanfilcon A Toric Lens
Description
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
Baseline
Title
Corneal Coverage - Fanfilcon A Toric Lens
Description
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
2-weeks
Title
Corneal Coverage - Fanfilcon A Toric Lens
Description
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Time Frame
4-weeks
Title
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Description
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time Frame
Baseline
Title
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Description
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
4-weeks
Title
Post-Blink Movement - Fanfilcon A Toric Lens
Description
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
Baseline
Title
Post-Blink Movement - Fanfilcon A Toric Lens
Description
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
2-weeks
Title
Post-Blink Movement - Fanfilcon A Toric Lens
Description
Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame
4-weeks
Title
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Description
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame
Baseline
Title
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Description
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame
4-weeks
Title
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Description
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame
Baseline
Title
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Description
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame
2-weeks
Title
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Description
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens
Description
Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.
Time Frame
4 weeks
Title
Average Daily Wearing Time - Fanfilcon A Toric Lens
Description
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame
2 weeks
Title
Average Daily Wearing Time - Fanfilcon A Toric Lens
Description
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens
Description
Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day
Time Frame
4 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Description
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame
2 weeks
Title
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Description
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted soft toric contact lens wearer
Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)
Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule
Exclusion Criteria:
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:
Pathological dry eye or associated findings
Pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruben Velázquez Guerrero, MSc., FIACLE
Organizational Affiliation
School of Optometry, National Autonomous University (UNAM), Mexico City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic, National Autonomous University
City
Mexico City
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
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