Clinical Evaluation of Stenfilcon A Contact Lenses

Clinical Evaluation of CooperVision MyDay Lenses

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: stenfilcon A lens; Device: narafilcon A lens

Detailed Description

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Fukusima
    • Fukushima, Fukusima, Japan, 960-8034
      • Shioya eye clinic
  • Kyoto
    • Terada, Kyoto, Japan, 610-0121
      • Kodama Eye Clinic
  • Tokyo
    • Shibuya, Tokyo, Japan, 15-0043
      • Itoi Eye Clinic
  • Yamaguchi
    • Shimonoseki, Yamaguchi, Japan, 751-0872
      • Ueda Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Is Japanese
• Has had a self-reported oculo-visual examination in the last two years.
• Is at least 18 years of age and has full legal capacity to volunteer.
• Has read and understood the informed consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Currently wears soft contact lenses.
• Has clear corneas and no active ocular disease.

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications that will affect ocular health.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stenfilcon A lens; MyDay contact lens	Device: stenfilcon A lens; contact lens; Other Names: MyDay, test
Active Comparator: narafilcon A lens; 1-Day Acuvue TruEye	Device: narafilcon A lens; contact lens; Other Names: 1-day Acuvue TruEye, control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Movement	Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)	5 minutes
Lens Movement	Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)	3hrs
Horizontal Lens Centration	Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)	5 minutes
Horizontal Lens Centration	Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)	3hrs
Vertical Lens Centration	Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)	5 minutes
Vertical Lens Centration	Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)	3hrs
Corneal Coverage	Does lens cover the cornea: (Yes, No)	5 minutes
Corneal Coverage	Does lens cover the cornea: (Yes, No)	3hrs
Lens Lag	Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)	5 minutes
Lens Lag	Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)	3hrs
Overall Fitting Performance	Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)	5 minutes
Overall Fitting Performance	Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)	3hrs
Investigator Fit Preference	Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)	5 minutes
Investigator Fit Preference	Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)	3hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))	Baseline
Comfort	Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))	5 Minutes
Comfort	Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))	3 hours
Dryness	Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))	Baseline
Dryness	Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))	5 minutes
Dryness	Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))	3 hours
Stinging/Burning	Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))	Baseline
Stinging/Burning	Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))	5 minutes
Stinging/Burning	Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))	3 hours
Edge/Lens Awareness	Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))	Baseline
Edge/Lens Awareness	Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))	5 minutes
Edge/Lens Awareness	Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))	3 hours
Subjective Lens Preference	Lens preference (stenfilcon A, Either, Neither, narafilcon A)	Baseline
Subjective Lens Preference	Lens preference (stenfilcon A, Either, Neither, narafilcon A)	5 minutes
Subjective Lens Preference	Lens preference (stenfilcon A, Either, Neither, narafilcon A)	3 hours

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Yuji Kodama, MD, PhD, Kodama Eye Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): April 25, 2018
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 19, 2018
• First Posted (Actual): March 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: JP-MKTG-201709_02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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