Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

Astigmatism Clinical Trial

Official title:

Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050605
• Other study ID #: EX-MKTG-102
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: October 18, 2019

Study information

• Verified date: September 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 18, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• somofilcon A toric contact lens
Contact Lens
• fanfilcon A toric contact lens
Contact Lens

Locations

Country	Name	City	State
Mexico	Optometry Clinic, National Autonomous University	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Centration - Somofilcon A Toric (Habitual) Lens	Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Lens Centration - Somofilcon A Toric (Habitual) Lens	Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Primary	Lens Centration - Fanfilcon A Toric Lens	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Lens Centration - Fanfilcon A Toric Lens	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2-weeks
Primary	Lens Centration - Fanfilcon A Toric Lens	Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4-weeks
Primary	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Primary	Corneal Coverage - Somofilcon A Toric (Habitual ) Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4-weeks
Primary	Corneal Coverage - Fanfilcon A Toric Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Primary	Corneal Coverage - Fanfilcon A Toric Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	2-weeks
Primary	Corneal Coverage - Fanfilcon A Toric Lens	Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4-weeks
Primary	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)	Baseline
Primary	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).	4-weeks
Primary	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).	Baseline
Primary	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).	2-weeks
Primary	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).	4-weeks
Primary	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).	Baseline
Primary	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).	4-weeks
Primary	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).	Baseline
Primary	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).	2-weeks
Primary	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).	4-weeks
Secondary	Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens	Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.	4 weeks
Secondary	Average Daily Wearing Time - Fanfilcon A Toric Lens	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.	2 weeks
Secondary	Average Daily Wearing Time - Fanfilcon A Toric Lens	Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.	4 weeks
Secondary	Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens	Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day	4 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A Toric Lens	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.	2 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A Toric Lens	Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.	4 weeks