Cosmetic EffectNCT02173535

Quantitative Study of New Limbal Ring Prototypes

A study testing etafilcon test contact lens Variant AP, etafilcon test contact lens Variant JG and etafilcon test contact lens Variant CS in people with Cosmetic Effect, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for: Cosmetic Effect
What is being tested?: etafilcon test contact lens Variant AP, etafilcon test contact lens Variant JG and etafilcon test contact lens Variant CS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 257 participants
Where: 1 siteHong Kong
Study dates: 1 May 2014to 1 Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 39 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

The subject must be at least 18 years of age and no more than 39 years of age (inclusive)
Subjects must be Asian female
Subjects must be able to read Chinese
Subjects' monthly household income must be above HKD$ 10,000
Subjects must be habitual soft contact lens wearer or habitual limbal lens wearer or have a history of previous habitual lens wear.
Subjects' current/previous habitual lens must be in the disposable soft lens modality (ranging from daily to monthly)

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Subjects must have dark colored iris (black, brown, or brown hazel)
Subjects must be "concept acceptors". Concept acceptors are subjects that are willing to try new circle contact lenses.
Subjects must be classified as either 'Classic' or 'Vogue' on a Pattern Evaluation Screening Questionnaire.
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.
Subjects must have best corrected visual acuity of 20/40 (Snellen or equivalent) or better in each eye.
Subjects must possess a functional/usable pair of spectacles and bring them to the visit (only if applicable-to the investigators discretion)
Subjects must read, understand, and sign the Statement of Informed Consent
Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol

Who cannot join

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
Habitual wearers of rigid gas permeable lenses within the last 3 months
Habitual soft conventional contact lens wearers (conventional lenses defined as replacement modality of greater than 1 month)
Any color deficiencies, by self report
Currently pregnant or breast-feeding a baby
Diabetes

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Any ocular or systemic allergies or diseases which may interfere with contact lens wear
Any systemic disease, autoimmune disease, or use of medication which may interfere with contact lens wear, at the investigator's discretion
Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self report
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
Any active ocular abnormalities/conditions that may interfere with contact lens wear (this includes, but not limited to, chalazia, recurrent styes, pterygium, infection, etc.)
Any corneal distortion or moderate or above corneal distortion by self report
History of any corneal refractive surgery
Habitual contact lens is multifocal, monovision or worn as extended wear

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Study site
Hung Hom, Kowloon

Other trials in Hong Kong

About this study

Conditions: Cosmetic Effect
Being tested: etafilcon test contact lens Variant AP, etafilcon test contact lens Variant JG, etafilcon test contact lens Variant CS, etafilcon test contact lens Variant VC, etafilcon test contact lens Variant LA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

etafilcon test contact lens Variant APDevice
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
etafilcon test contact lens Variant JGDevice
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
etafilcon test contact lens Variant CSDevice
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
etafilcon test contact lens Variant VCDevice
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
etafilcon test contact lens Variant LADevice
Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.

Study groups in NCT02173535
Study group	Role	What they receive
etafilcon test contact lens Variant AP	Experimental	Not described Receives: Device: etafilcon test contact lens Variant AP; Device: etafilcon test contact lens Variant JG; Device: etafilcon test contact lens Variant CS; Device: etafilcon test contact lens Variant VC; Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant JG	Experimental	Not described Receives: Device: etafilcon test contact lens Variant AP; Device: etafilcon test contact lens Variant JG; Device: etafilcon test contact lens Variant CS; Device: etafilcon test contact lens Variant VC; Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant CS	Experimental	Not described Receives: Device: etafilcon test contact lens Variant AP; Device: etafilcon test contact lens Variant JG; Device: etafilcon test contact lens Variant CS; Device: etafilcon test contact lens Variant VC; Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant VC	Experimental	Not described Receives: Device: etafilcon test contact lens Variant AP; Device: etafilcon test contact lens Variant JG; Device: etafilcon test contact lens Variant CS; Device: etafilcon test contact lens Variant VC; Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant LA	Experimental	Not described Receives: Device: etafilcon test contact lens Variant AP; Device: etafilcon test contact lens Variant JG; Device: etafilcon test contact lens Variant CS; Device: etafilcon test contact lens Variant VC; Device: etafilcon test contact lens Variant LA

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subject in Agreement (Bigger Eyes)
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.
Measured: 15-20 Minutes Post Lens Insertion
Number of Subject in Agreement (Defines Eyes)
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.
Measured: 15-20 Minutes Post Lens Insertion
Number of Subject in Agreement (Enhance Eyes)
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.
Measured: 15-20 Minutes Post Lens Insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20141 Jun 2014

First posted25 Jun 2014 (estimated)
Study start1 May 2014
Primary completion1 Jun 2014
Study completion1 Jun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cosmetic EffectStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 257 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02173535
Sponsor's protocol ID: CR-5590
Status last verified: Jun 2017
First submitted: 20 May 2014
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantitative Study of New Limbal Ring Prototypes
ClinicalTrials.gov ID: NCT02173535
Acronym / sponsor ID: CR-5590
Conditions: Cosmetic Effect
Study type: Interventional
Recruitment status: Completed
Enrolment: 257 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 May 2014 (actual)
Primary completion: 1 Jun 2014 (actual)
Study completion: 1 Jun 2014 (actual)
First posted: 25 Jun 2014 (estimated)
Results: Posted 5 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
etafilcon test contact lens Variant AP	Experimental	Device: etafilcon test contact lens Variant AP, Device: etafilcon test contact lens Variant JG, Device: etafilcon test contact lens Variant CS, Device: etafilcon test contact lens Variant VC, Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant JG	Experimental	Device: etafilcon test contact lens Variant AP, Device: etafilcon test contact lens Variant JG, Device: etafilcon test contact lens Variant CS, Device: etafilcon test contact lens Variant VC, Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant CS	Experimental	Device: etafilcon test contact lens Variant AP, Device: etafilcon test contact lens Variant JG, Device: etafilcon test contact lens Variant CS, Device: etafilcon test contact lens Variant VC, Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant VC	Experimental	Device: etafilcon test contact lens Variant AP, Device: etafilcon test contact lens Variant JG, Device: etafilcon test contact lens Variant CS, Device: etafilcon test contact lens Variant VC, Device: etafilcon test contact lens Variant LA
etafilcon test contact lens Variant LA	Experimental	Device: etafilcon test contact lens Variant AP, Device: etafilcon test contact lens Variant JG, Device: etafilcon test contact lens Variant CS, Device: etafilcon test contact lens Variant VC, Device: etafilcon test contact lens Variant LA

Who may qualify

Ages: 18 to 39 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

The subject must be at least 18 years of age and no more than 39 years of age (inclusive)
Subjects must be Asian female
Subjects must be able to read Chinese
Subjects' monthly household income must be above HKD$ 10,000
Subjects must be habitual soft contact lens wearer or habitual limbal lens wearer or have a history of previous habitual lens wear.

Key exclusion criteria (14 listed)

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
Habitual wearers of rigid gas permeable lenses within the last 3 months
Habitual soft conventional contact lens wearers (conventional lenses defined as replacement modality of greater than 1 month)
Any color deficiencies, by self report
Currently pregnant or breast-feeding a baby

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
etafilcon test contact lens Variant APSubject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.	Device	etafilcon test contact lens Variant AP, etafilcon test contact lens Variant CS, etafilcon test contact lens Variant JG, etafilcon test contact lens Variant LA, etafilcon test contact lens Variant VC
etafilcon test contact lens Variant JGSubject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.	Device	etafilcon test contact lens Variant AP, etafilcon test contact lens Variant CS, etafilcon test contact lens Variant JG, etafilcon test contact lens Variant LA, etafilcon test contact lens Variant VC
etafilcon test contact lens Variant CSSubject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.	Device	etafilcon test contact lens Variant AP, etafilcon test contact lens Variant CS, etafilcon test contact lens Variant JG, etafilcon test contact lens Variant LA, etafilcon test contact lens Variant VC
etafilcon test contact lens Variant VCSubject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.	Device	etafilcon test contact lens Variant AP, etafilcon test contact lens Variant CS, etafilcon test contact lens Variant JG, etafilcon test contact lens Variant LA, etafilcon test contact lens Variant VC
etafilcon test contact lens Variant LASubject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.	Device	etafilcon test contact lens Variant AP, etafilcon test contact lens Variant CS, etafilcon test contact lens Variant JG, etafilcon test contact lens Variant LA, etafilcon test contact lens Variant VC

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 5 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AP-CS-LA-JG-VC	12	12
AP-JG-CS-VC-LA	12	12
AP-LA-VC-CS-JG	12	12
AP-VC-JG-LA-CS	12	12
CS-AP-VC-JG-LA	12	12
CS-JG-AP-LA-VC	12	12
CS-VC-LA-AP-JG	12	12
CS-LA-JG-VC-AP	12	12
JG-AP-LA-VC-CS	12	12
JG-CS-VC-LA-AP	12	12
JG-LA-CS-AP-VC	12	12
JG-VC-AP-CS-LA	12	12
LA-AP-JG-CS-VC	12	12
LA-CS-AP-VC-JG	12	12
LA-JG-VC-AP-CS	12	12
LA-VC-CS-JG-AP	12	12
VC-AP-CS-LA-JG	12	12
VC-CS-JG-AP-LA	12	12
VC-JG-LA-CS-AP	12	12
VC-LA-AP-JG-CS	12	12

Primary outcome: Number of Subject in Agreement (Bigger Eyes)

Time frame: 15-20 Minutes Post Lens Insertion. Number. Unit: Participants

Measure	AP- Etafilcon A n = 236	CS- Etafilcon A n = 236	JG-etafilcon A n = 236	LA-etafilcon A n = 236	VC- Etafilcon A n = 236
Value	187	213	206	209	208

Population analysed: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints

Primary outcome: Number of Subject in Agreement (Defines Eyes)

Time frame: 15-20 Minutes Post Lens Insertion. Number. Unit: Participants

Measure	AP- Etafilcon A n = 236	CS- Etafilcon A n = 236	JG-etafilcon A n = 236	LA-etafilcon A n = 236	VC- Etafilcon A n = 236
Value	175	189	180	188	192

Population analysed: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints

Primary outcome: Number of Subject in Agreement (Enhance Eyes)

Time frame: 15-20 Minutes Post Lens Insertion. Number. Unit: Participants

Measure	AP- Etafilcon A n = 236	CS- Etafilcon A n = 236	JG-etafilcon A n = 236	LA-etafilcon A n = 236	VC- Etafilcon A n = 236
Value	167	180	177	170	185

Population analysed: Subjects that completed all study visits without a major protocol deviation impacting any of the primary endpoints

Adverse events

Time frame: Throughout the duration of the study. Approximately 2 hours per subject. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AP-CS-LA-JG-VC	0 of 12 (0%)	0 of 12 (0%)	Not reported
AP-JG-CS-VC-LA	0 of 12 (0%)	0 of 12 (0%)	Not reported
AP-LA-VC-CS-JG	0 of 12 (0%)	0 of 12 (0%)	Not reported
AP-VC-JG-LA-CS	0 of 12 (0%)	0 of 12 (0%)	Not reported
CS-AP-VC-JG-LA	0 of 12 (0%)	0 of 12 (0%)	Not reported
CS-JG-AP-LA-VC	0 of 12 (0%)	0 of 12 (0%)	Not reported
CS-VC-LA-AP-JG	0 of 12 (0%)	0 of 12 (0%)	Not reported
CS-LA-JG-VC-AP	0 of 12 (0%)	0 of 12 (0%)	Not reported
JG-AP-LA-VC-CS	0 of 12 (0%)	0 of 12 (0%)	Not reported
JG-CS-VC-LA-AP	0 of 12 (0%)	0 of 12 (0%)	Not reported
JG-LA-CS-AP-VC	0 of 12 (0%)	0 of 12 (0%)	Not reported
JG-VC-AP-CS-LA	0 of 12 (0%)	0 of 12 (0%)	Not reported
LA-AP-JG-CS-VC	0 of 12 (0%)	0 of 12 (0%)	Not reported
LA-CS-AP-VC-JG	0 of 12 (0%)	0 of 12 (0%)	Not reported
LA-JG-VC-AP-CS	0 of 12 (0%)	0 of 12 (0%)	Not reported
LA-VC-CS-JG-AP	0 of 12 (0%)	0 of 12 (0%)	Not reported
VC-AP-CS-LA-JG	0 of 12 (0%)	0 of 12 (0%)	Not reported
VC-CS-JG-AP-LA	0 of 12 (0%)	0 of 12 (0%)	Not reported
VC-JG-LA-CS-AP	0 of 12 (0%)	0 of 12 (0%)	Not reported
VC-LA-AP-JG-CS	0 of 12 (0%)	0 of 12 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subject in Agreement (Bigger Eyes) (time frame: 15-20 Minutes Post Lens Insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02173535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.