Clinical Evaluation of Stenfilcon A Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of CooperVision MyDay Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471832
• Other study ID #: JP-MKTG-201709_02
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: April 25, 2018

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• stenfilcon A lens
contact lens
• narafilcon A lens
contact lens

Locations

Country	Name	City	State
Japan	Shioya Eye Clinic	Fukushima	Fukusima
Japan	Itoi Eye Clinic	Shibuya	Tokyo
Japan	Ueda Eye Clinic	Shimonoseki	Yamaguchi
Japan	Kodama Eye Clinic	Terada	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Movement	Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)	5 minutes
Primary	Lens Movement	Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)	3hrs
Primary	Horizontal Lens Centration	Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)	5 minutes
Primary	Horizontal Lens Centration	Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)	3hrs
Primary	Vertical Lens Centration	Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)	5 minutes
Primary	Vertical Lens Centration	Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)	3hrs
Primary	Corneal Coverage	Does lens cover the cornea: (Yes, No)	5 minutes
Primary	Corneal Coverage	Does lens cover the cornea: (Yes, No)	3hrs
Primary	Lens Lag	Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)	5 minutes
Primary	Lens Lag	Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)	3hrs
Primary	Overall Fitting Performance	Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)	5 minutes
Primary	Overall Fitting Performance	Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)	3hrs
Primary	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
Primary	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	Comfort	Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))	Baseline
Secondary	Comfort	Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))	5 Minutes
Secondary	Comfort	Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))	3 hours
Secondary	Dryness	Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))	Baseline
Secondary	Dryness	Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))	5 minutes
Secondary	Dryness	Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))	3 hours
Secondary	Stinging/Burning	Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))	Baseline
Secondary	Stinging/Burning	Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))	5 minutes
Secondary	Stinging/Burning	Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))	3 hours
Secondary	Edge/Lens Awareness	Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))	Baseline
Secondary	Edge/Lens Awareness	Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))	5 minutes
Secondary	Edge/Lens Awareness	Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))	3 hours
Secondary	Subjective Lens Preference	Lens preference (stenfilcon A, Either, Neither, narafilcon A)	Baseline
Secondary	Subjective Lens Preference	Lens preference (stenfilcon A, Either, Neither, narafilcon A)	5 minutes
Secondary	Subjective Lens Preference	Lens preference (stenfilcon A, Either, Neither, narafilcon A)	3 hours