Clinical Evaluation of Stenfilcon A Contact Lenses

NCT03471832 | Completed Results FDA Device

• 1 other identifier: JP-MKTG-201709_02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (15)

• Comfort

  Baseline

• Comfort

  5 Minutes

• Comfort

  3 hours

• Dryness

  Baseline

• Dryness

  5 minutes

Study Arms (2)

stenfilcon A lens

EXPERIMENTAL

MyDay contact lens

Device: stenfilcon A lens

narafilcon A lens

ACTIVE COMPARATOR

1-Day Acuvue TruEye

Device: narafilcon A lens

Interventions

stenfilcon A lens DEVICE

contact lens

Also known as: MyDay, test

stenfilcon A lens

narafilcon A lens DEVICE

contact lens

Also known as: 1-day Acuvue TruEye, control

narafilcon A lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (4)

Shioya Eye Clinic

Fukushima, Fukushima, 960-8034, Japan

Location

Kodama Eye Clinic

Terada, Kyoto, 610-0121, Japan

Location

Itoi Eye Clinic

Shibuya City, Tokyo, 15-0043, Japan

Location

Ueda Eye Clinic

Shimonoseki, Yamaguchi, 751-0872, Japan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A.Vega, O.D., MSc., FAAO
• Organization: CooperVision

javega@coopervision.com

9256213761

Study Officials

• Yuji Kodama, MD, PhD

  Kodama Eye Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Each subject will be masked as to which lens is worn on each eye.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: March 3, 2018
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: January 29, 2020
• Results First Posted: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)