Clinical trial NCT03471832: Clinical Evaluation of Stenfilcon A Contact Lenses
Official title: Clinical Evaluation of CooperVision MyDay Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2018-03-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a non-dispensing, randomized, contralateral study comparing a test lens against the appropriate control lens.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lens Movement
timeFrame: 5 minutes
measure: Lens Movement
timeFrame: 3hrs
measure: Horizontal Lens Centration
timeFrame: 5 minutes
measure: Horizontal Lens Centration
timeFrame: 3hrs
measure: Vertical Lens Centration
timeFrame: 5 minutes
measure: Vertical Lens Centration
timeFrame: 3hrs
measure: Corneal Coverage
timeFrame: 5 minutes
measure: Corneal Coverage
timeFrame: 3hrs
measure: Lens Lag
timeFrame: 5 minutes
measure: Lens Lag
timeFrame: 3hrs
measure: Overall Fitting Performance
timeFrame: 5 minutes
measure: Overall Fitting Performance
timeFrame: 3hrs
measure: Investigator Fit Preference
timeFrame: 5 minutes
measure: Investigator Fit Preference
timeFrame: 3hrs
Secondary outcomes:
measure: Comfort
timeFrame: Baseline
measure: Comfort
timeFrame: 5 Minutes
measure: Comfort
timeFrame: 3 hours
measure: Dryness
timeFrame: Baseline
measure: Dryness
timeFrame: 5 minutes
measure: Dryness
timeFrame: 3 hours
measure: Stinging/Burning
timeFrame: Baseline
measure: Stinging/Burning
timeFrame: 5 minutes
measure: Stinging/Burning
timeFrame: 3 hours
measure: Edge/Lens Awareness
timeFrame: Baseline
measure: Edge/Lens Awareness
timeFrame: 5 minutes
measure: Edge/Lens Awareness
timeFrame: 3 hours
measure: Subjective Lens Preference
timeFrame: Baseline
measure: Subjective Lens Preference
timeFrame: 5 minutes
measure: Subjective Lens Preference
timeFrame: 3 hours
Other outcomes:
Locations:
city: Fukushima
country: Japan
facility: Shioya Eye Clinic
state: Fukusima
city: Terada
country: Japan
facility: Kodama Eye Clinic
state: Kyoto
city: Shibuya
country: Japan
facility: Itoi Eye Clinic
state: Tokyo
city: Shimonoseki
country: Japan
facility: Ueda Eye Clinic
state: Yamaguchi
Study officials:
affiliation: Kodama Eye Clinic
name: Yuji Kodama, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: