Quantitative Study of New Limbal Ring Prototypes

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.
The study is designed to test five new soft contact lens color pattern variants to determine whether the test lens makes the wearers eyes look bigger, more defined or enhances their overall appearance.

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.

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.
257

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

  • Hong Kong
    • Kowloon
      • Hung Hom, Kowloon, Hong Kong

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 to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. The subject must be at least 18 years of age and no more than 39 years of age (inclusive)
  2. Subjects must be Asian female
  3. Subjects must be able to read Chinese
  4. Subjects' monthly household income must be above HKD$ 10,000
  5. Subjects must be habitual soft contact lens wearer or habitual limbal lens wearer or have a history of previous habitual lens wear.
  6. Subjects' current/previous habitual lens must be in the disposable soft lens modality (ranging from daily to monthly)
  7. Subjects must have dark colored iris (black, brown, or brown hazel)
  8. Subjects must be "concept acceptors". Concept acceptors are subjects that are willing to try new circle contact lenses.
  9. Subjects must be classified as either 'Classic' or 'Vogue' on a Pattern Evaluation Screening Questionnaire.
  10. Subjects must have acceptable near vision (without vision correction) and be able to see the test article lenses in the mirror 30 cm or closer.
  11. Subjects must have best corrected visual acuity of 20/40 (Snellen or equivalent) or better in each eye.
  12. Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable-to the investigators discretion)
  13. Subjects must read, understand, and sign the Statement of Informed Consent
  14. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol

Exclusion Criteria:

  1. Subjects, or subjects' family member within the same household, that work for the following entities/companies: Government, advertising, marketing research or consultancy, media or public relations, companies that make, distribute or sell eyewear or contact lenses, eyecare practice (optometrist, ophthalmologist, optician) or the research center conducting the study
  2. Habitual wearers of rigid gas permeable lenses within the last 3 months
  3. Habitual soft conventional contact lens wearers (conventional lenses defined as replacement modality of greater than 1 month)
  4. Any color deficiencies, by self report
  5. Currently pregnant or breast-feeding a baby
  6. Diabetes
  7. Any ocular or systemic allergies or diseases which may interfere with contact lens wear
  8. Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear, at the investigator's discretion
  9. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self report
  10. Any grade 3 or greater Biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale
  11. Any active ocular abnormalities/conditions that may interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styes, pterygium, infection, etc.)
  12. Any corneal distortion or moderate or above corneal distortion by self report
  13. History of any corneal refractive surgery
  14. Habitual contact lens is multifocal, monovision or worn as extended wear

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: etafilcon test contact lens Variant AP
Device: etafilcon test contact lens Variant AP
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant JG
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant CS
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant VC
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant LA
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Experimental: etafilcon test contact lens Variant JG
Device: etafilcon test contact lens Variant AP
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant JG
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant CS
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant VC
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant LA
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Experimental: etafilcon test contact lens Variant CS
Device: etafilcon test contact lens Variant AP
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant JG
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant CS
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant VC
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant LA
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Experimental: etafilcon test contact lens Variant VC
Device: etafilcon test contact lens Variant AP
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant JG
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant CS
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant VC
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant LA
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Experimental: etafilcon test contact lens Variant LA
Device: etafilcon test contact lens Variant AP
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant JG
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant CS
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant VC
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Device: etafilcon test contact lens Variant LA
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.

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
Number of Subject in Agreement (Bigger Eyes)
Time Frame: 15-20 Minutes Post Lens Insertion
Subjects' responses to the question "Make my eye look bigger" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
15-20 Minutes Post Lens Insertion
Number of Subject in Agreement (Defines Eyes)
Time Frame: 15-20 Minutes Post Lens Insertion
Subjects' responses to the question "Define my eye" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
15-20 Minutes Post Lens Insertion
Number of Subject in Agreement (Enhance Eyes)
Time Frame: 15-20 Minutes Post Lens Insertion
Subjects' responses to the question "Enhance my overall appearance" were categorized into a binary variable. If a subject responded "Agrees Somewhat" or "Agrees Strongly" then response=1. If a subject responds "Neither Agrees nor Disagrees", "Disagrees Somewhat" "Disagrees Strongly" then response=0. The number of subjects with response=1 was reported for each lens.
15-20 Minutes Post Lens Insertion

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.
Johnson & Johnson Vision Care, Inc.

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.
May 1, 2014

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.
June 1, 2014

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.
June 1, 2014

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).
May 20, 2014

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.
June 23, 2014

First Posted (Estimate)

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.
June 25, 2014

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.
June 19, 2018

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.
June 18, 2018

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.
June 1, 2017

More Information

Terms related to this study

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.
  • CR-5590

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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