Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Myopia Clinical Trial

Official title:

Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974802
• Other study ID #: EX-MKTG-101
• Status: Completed
• Phase: N/A
• Start date: May 14, 2019
• Est. completion date: August 28, 2019

Study information

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

Clinical Trial Summary

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.

Description:

The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 28, 2019
• Est. primary completion date: July 24, 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 contact lens wearer

• Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)

• Have no less than -0.75D of astigmatism 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 of = 1.00D 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

• Myopia

Intervention

Device:
• somofilcon A contact lens
Contact Lens
• fanfilcon A 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 for Somofilcon A (Habitual) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Lens Centration for Somofilcon A (Habitual) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4- weeks
Primary	Lens Centration for Fanfilcon A (Test) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Primary	Lens Centration for Fanfilcon A (Test) Lens	Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2-weeks
Primary	Lens Centration for Fanfilcon A (Test) Lens	Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4- weeks
Primary	Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Primary	Lens Corneal Coverage for Somofilcon A (Habitual) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4 -weeks
Primary	Lens Corneal Coverage for Fanfilcon A (Test) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	Baseline
Primary	Lens Corneal Coverage for Fanfilcon A (Test) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	2-weeks
Primary	Lens Corneal Coverage for Fanfilcon A (Test) Lens	Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)	4-weeks
Primary	Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	Baseline
Primary	Percentage of Lens Tightness for Somofilcon A (Habitual) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	4-Weeks
Primary	Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	Baseline
Primary	Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	2-Weeks
Primary	Percentage of Lens Tightness for Fanfilcon A (Test) Lens	Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)	4-Weeks
Primary	Post-Blink Movement for Somofilcon A (Habitual) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	Baseline
Primary	Post-Blink Movement for Somofilcon A (Habitual) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	4-weeks
Primary	Post-Blink Movement for Fanfilcon A (Test) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	Baseline
Primary	Post-Blink Movement for Fanfilcon A (Test) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	2-weeks
Primary	Post-Blink Movement for Fanfilcon A (Test) Lens	Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)	4-weeks
Primary	Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Somofilcon A (Habitual) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens	Overall fit acceptance was measured using a scale of 0-4 (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 (Habitual) Lens	Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day	4-weeks
Secondary	Average Daily Wearing Time - Fanfilcon A (Test) Lens	Average daily wearing time for fanfilcon A (test) lens was measured in hours/day	2-weeks
Secondary	Average Daily Wearing Time - Fanfilcon A (Test) Lens	Average daily wearing time for fanfilcon A (test) lens was measured in hours/day	4-weeks
Secondary	Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens	Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.	4 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.	2 weeks
Secondary	Average Comfortable Wearing Time - Fanfilcon A (Test) Lens	Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.	4 weeks