Clinical Evaluation of Stenfilcon A Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: narafilcon A lens; Device: stenfilcon A lens

• Registration Number: NCT03471832
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2018-03-03
• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-19
• Study First Posted: 2018-03-21
• Primary Completion: 2018-04-25
• Study Completion: 2018-04-25
• Disposition First Submitted: 2019-07-30
• Disposition First Submitted QC: 2019-07-30
• Results First Submitted: 2019-12-12
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Results First Posted: 2020-01-29
• Disposition First Posted: 2020-01-29
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
narafilcon A lens	narafilcon A lens	1-Day Acuvue TruEye
stenfilcon A lens	stenfilcon A lens	MyDay contact lens

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Shioya Eye Clinic; 🇯🇵 Fukushima, Fukusima, Japan

Kodama Eye Clinic; 🇯🇵 Terada, Kyoto, Japan

Ueda Eye Clinic; 🇯🇵 Shimonoseki, Yamaguchi, Japan

Itoi Eye Clinic; 🇯🇵 Shibuya, Tokyo, Japan