Refractive ErrorNCT01882465

Corneal Staining Associated With Daily Disposable Beauty Contact Lenses

A study testing etafilcon A, 2-HEMA, EGDMA Non-ionic and hefilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Limbal ring contact lenses enhance the look of the eye by adding pigmentation in a ring pattern to the contact lens. The purpose of this investigation is to determine if corneal staining increase is dependent upon the lens pigment location. Read more about this study

Who is it for?: Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Refractive Error
What is being tested?: etafilcon A, 2-HEMA, EGDMA Non-ionic and hefilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteHong Kong
Study dates: Aug 2013to Aug 2013
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 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Fluency in English and ability to read and understand written English.
The subject must be able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between 18 and 35 years of age.
The subject must be an adapted (minimum of 4 week history of daily wear prior to the baseline study visit) soft contact lens wearer in both eyes.
The subject must be East or Southeast Asia descent, e.g. ethnic Chinese, Japanese, Korean, Malay, Vietnamese, Indonesian, Filipino, etc. by self-report.

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The subject must come in with a current (no more than 12 month old) spectacle or contact lens prescription as indicated. (NB: Emmetropic subjects who wear contact lenses for enhancement purposes only will also require a current contact lens prescription).
The subject's vertex corrected spherical equivalent distance refraction must be in the range of PLANO to -6.00 Diopter (D) in each eye.
The subject must have best corrected visual acuity on +0.24 logMAR (equivalent to 20/30 (-2)) or better in each eye.
The subject must own a wearable pair of spectacles (as indicated by current prescription) and wear them to all visits including the screening visit as required for vision correction. They must be willing to wear their spectacles during the 24 hour washout period leading up to each treatment visit (NB: Emmetropic subjects who do not own spectacles must agree to no lens wear on all visit days including the screening visit).
The subject must have normal eye (i.e., no ocular medications or infections of any type).

Who cannot join

Are currently pregnant or lactating, determined by self-report (subjects who become pregnant during the study will be discontinued).
Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
Use any topical medication such as eye drops or ointment.
Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
Had any previous, or have planned, ocular or intraocular surgery (e.g., cataract surgery, radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK).

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Have any grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron classification scale or any other ocular abnormality that may contraindicate contact lens wear.
Have any known hypersensitivity or allergic reaction to contact lenses (as assessed by ocular history).
Have any ocular infection.
Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
Have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
Currently wear their contact lenes on an extended wear basis.
Is an employee of the investigational clinic (e.g., Investigator, Coordinator, Technician).
Currently wears toric or multifocal contact lenses. If the subject wears soft contact lenses for monovision, they must be willing to wear distance only correction in both eyes for the study.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Hong Kong Polytechnic University
Hong Hom, Kowloon

Other trials in Hong Kong

About this study

Conditions: Refractive Error
Being tested: etafilcon A, 2-HEMA, EGDMA Non-ionic, hefilcon A
Medical subject headings: Refractive Errors

What participants receive

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

etafilcon ADevice
Also called 1-Day Acuvue DEFINE (Vivid)
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
2-HEMA, EGDMA Non-ionicDevice
Also called SEED Eye Coffret 1-Day UV Rich Make
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
hefilcon ADevice
Also called Ticon Cosmetic Daily Black
Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.

Study groups in NCT01882465
Study group	Role	What they receive
etafilcon A/2-HEMA, EGDMA/hefilcon A	Other	Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. Receives: Device: etafilcon A; Device: 2-HEMA, EGDMA Non-ionic; Device: hefilcon A
etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic	Other	Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. Receives: Device: etafilcon A; Device: 2-HEMA, EGDMA Non-ionic; Device: hefilcon A
2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A	Other	Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. Receives: Device: etafilcon A; Device: 2-HEMA, EGDMA Non-ionic; Device: hefilcon A
2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A	Other	Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. Receives: Device: etafilcon A; Device: 2-HEMA, EGDMA Non-ionic; Device: hefilcon A
hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A	Other	Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. Receives: Device: etafilcon A; Device: 2-HEMA, EGDMA Non-ionic; Device: hefilcon A
hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic	Other	Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit. Receives: Device: etafilcon A; Device: 2-HEMA, EGDMA Non-ionic; Device: hefilcon A

What is being measured

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

Corneal Staining
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.
Measured: 20 minutes and 7 hours post lens fitting

Timeline

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

Aug 2013Aug 2013

First posted20 Jun 2013 (estimated)
Study startAug 2013
Primary completionAug 2013
Study completionAug 2013

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 Refractive ErrorStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01882465
Sponsor's protocol ID: CR-5360
Status last verified: Nov 2016
First submitted: 7 Jun 2013
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?

See locations

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Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
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Recruiting
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All Refractive Error trials

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: Corneal Staining Associated With Daily Disposable Beauty Contact Lenses
ClinicalTrials.gov ID: NCT01882465
Acronym / sponsor ID: CR-5360
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Terminated
Enrolment: 35 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 20 Jun 2013 (estimated)
Results: Posted 5 Oct 2016

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
etafilcon A/2-HEMA, EGDMA/hefilcon A	Other	Device: etafilcon A, Device: 2-HEMA, EGDMA Non-ionic, Device: hefilcon ASubjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic	Other	Device: etafilcon A, Device: 2-HEMA, EGDMA Non-ionic, Device: hefilcon ASubjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A	Other	Device: etafilcon A, Device: 2-HEMA, EGDMA Non-ionic, Device: hefilcon ASubjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A	Other	Device: etafilcon A, Device: 2-HEMA, EGDMA Non-ionic, Device: hefilcon ASubjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A	Other	Device: etafilcon A, Device: 2-HEMA, EGDMA Non-ionic, Device: hefilcon ASubjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic	Other	Device: etafilcon A, Device: 2-HEMA, EGDMA Non-ionic, Device: hefilcon ASubjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Fluency in English and ability to read and understand written English.
The subject must be able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be between 18 and 35 years of age.
The subject must be an adapted (minimum of 4 week history of daily wear prior to the baseline study visit) soft contact lens wearer in both eyes.

Key exclusion criteria (15 listed)

Are currently pregnant or lactating, determined by self-report (subjects who become pregnant during the study will be discontinued).
Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Have any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but may not be limited to diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndromes, xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
Use any topical medication such as eye drops or ointment.
Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

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 AAlso: 1-Day Acuvue DEFINE (Vivid)Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Device	2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A, 2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A, etafilcon A/2-HEMA, EGDMA/hefilcon A, etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic, hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A, hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic
2-HEMA, EGDMA Non-ionicAlso: SEED Eye Coffret 1-Day UV Rich MakeLenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Device	2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A, 2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A, etafilcon A/2-HEMA, EGDMA/hefilcon A, etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic, hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A, hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic
hefilcon AAlso: Ticon Cosmetic Daily BlackLenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Device	2-HEMA, EGDMA Non-ionic/etafilcon A/hefilcon A, 2-HEMA, EGDMA Non-ionic/hefilcon A/etafilcon A, etafilcon A/2-HEMA, EGDMA/hefilcon A, etafilcon A/hefilcon A/2-HEMA, EGDMA Non-ionic, hefilcon A/2-HEMA, EGDMA Non-ionic/etafilcon A, hefilcon A/etafilcon A /2-HEMA, EGDMA Non-ionic

Primary outcome

Corneal Staining
Time frame: 20 minutes and 7 hours post lens fitting
Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.

Results and safety

Results posted to the registry on 5 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Etafilcon A/2-HEMA, EGDMA/Hefilcon A	6	6
Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic	6	6
2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A	5	5
2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A	6	5
Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A	5	5
Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic	5	5
Not Assigned	1	0

Primary outcome: Corneal Staining

Time frame: 20 minutes and 7 hours post lens fitting. Mean (Standard Deviation). Unit: units on a scale

Measure	Etafilcon A n = 31	2-HEMA, EGDMA Non-ionic n = 31	Hefilcon A n = 32
Baseline: 20 Minutes	0.26 (0.569)	0.15 (0.580)	0.29 (0.624)
7 Hours Post Lens Fitting	-0.04 (1.154)	0.49 (1.090)	-0.02 (1.233)

Population analysed: All subjects that completed every study visit without a major protocol deviation.

Adverse events

Time frame: Throughout the duration of the study- approximately 3 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A	0 of 34 (0%)	0 of 34 (0%)	Not reported
2-HEMA, EGDMA Non-ionic	0 of 34 (0%)	0 of 34 (0%)	Not reported
Hefilcon A	0 of 34 (0%)	0 of 34 (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?

A study testing etafilcon A, 2-HEMA, EGDMA Non-ionic and hefilcon A in people with Refractive Error, run by Johnson & Johnson Vision Care, Inc. at 1 site in Hong Kong.

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 11 inclusion and 15 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: stopped early, 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 Oct 2016). 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?

Corneal Staining (time frame: 20 minutes and 7 hours post lens fitting). 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 NCT01882465.

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.