Clinical Evaluation of Stenfilcon A Contact Lenses

January 14, 2020 updated by: CooperVision, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lens Movement
Time Frame: 5 minutes
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
5 minutes
Lens Movement
Time Frame: 3hrs
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
3hrs
Horizontal Lens Centration
Time Frame: 5 minutes
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
5 minutes
Horizontal Lens Centration
Time Frame: 3hrs
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
3hrs
Vertical Lens Centration
Time Frame: 5 minutes
Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)
5 minutes
Vertical Lens Centration
Time Frame: 3hrs
Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)
3hrs
Corneal Coverage
Time Frame: 5 minutes
Does lens cover the cornea: (Yes, No)
5 minutes
Corneal Coverage
Time Frame: 3hrs
Does lens cover the cornea: (Yes, No)
3hrs
Lens Lag
Time Frame: 5 minutes
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
5 minutes
Lens Lag
Time Frame: 3hrs
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
3hrs
Overall Fitting Performance
Time Frame: 5 minutes
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
5 minutes
Overall Fitting Performance
Time Frame: 3hrs
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
3hrs
Investigator Fit Preference
Time Frame: 5 minutes
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
Time Frame: 3hrs
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: Baseline
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
Baseline
Comfort
Time Frame: 5 Minutes
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
5 Minutes
Comfort
Time Frame: 3 hours
Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))
3 hours
Dryness
Time Frame: Baseline
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
Baseline
Dryness
Time Frame: 5 minutes
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
5 minutes
Dryness
Time Frame: 3 hours
Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))
3 hours
Stinging/Burning
Time Frame: Baseline
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
Baseline
Stinging/Burning
Time Frame: 5 minutes
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
5 minutes
Stinging/Burning
Time Frame: 3 hours
Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))
3 hours
Edge/Lens Awareness
Time Frame: Baseline
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
Baseline
Edge/Lens Awareness
Time Frame: 5 minutes
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
5 minutes
Edge/Lens Awareness
Time Frame: 3 hours
Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))
3 hours
Subjective Lens Preference
Time Frame: Baseline
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
Baseline
Subjective Lens Preference
Time Frame: 5 minutes
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
5 minutes
Subjective Lens Preference
Time Frame: 3 hours
Lens preference (stenfilcon A, Either, Neither, narafilcon A)
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CooperVision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuji Kodama, MD, PhD, Kodama Eye Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 25, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 25, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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