Refractive AmetropiaNCT01484028

Evaluation of the Performance of Two Contact Lenses Compared to a Marketed Lens

A study testing etafilcon A with print and PVP for light eyes (EALE) and etafilcon A with print and PVP for dark eyes (EADE) in people with Refractive Ametropia, run by Johnson & Johnson Vision Care, Inc. at 15 sites in United States.

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

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens. Read more about this study

Who is it for?: Ages 18 to 34 years, women only
Conditions the study is for: Refractive Ametropia
What is being tested?: etafilcon A with print and PVP for light eyes (EALE) and etafilcon A with print and PVP for dark eyes (EADE)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 15 sitesUnited States
Study dates: Nov 2011to Feb 2012
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 34 years
Women only
No healthy volunteers
Adult

Who may be able to join

Healthy, female adult, at least 18 years of age, and no more than 34 years of age
The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
Any cylinder power must be: <=0.75D
Visual acuity must be best correctable to 20/25 or better for each eye

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Must have normal eyes (no ocular medications or ocular infection of any type)
Must read and sign the Statement of Informed Consent
Must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Who cannot join

Ocular or systemic allergies or disease which might interfere with contact lens wear
Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
Any ocular infection
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear

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Any color deficiencies (colorblindness) - to the best of the subject's knowledge
Pregnancy or lactation
Diabetes
Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV)
Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Subject presents with one dark iris color and one light iris color.
Subject has heterochromia iridis (a difference in color between parts of one iris).
The subject must not be an employee or family member of the clinical study site.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Eye Care Associates
Bloomington, Illinois, 61701
Vision Care
East Lansing, Michigan, 48826
The Eye Care Group
Grants Pass, Oregon, 97526
Spectrum Eye Care
Jamestown, New York, 14702
Wishnow Sugar Group
Katy, Texas, 77450
Snowy Range Cision Center
Laramie, Wyoming, 82070
Isthmus Eye Care
Middleton, Wisconsin, 53562
Advanced Optometry
Mission Viejo, California, 92691
James R Dugue, Optometrist
Mission Viejo, California, 92691
Advance Eye Care
Pismo Beach, California, 93448
Kannarr Eye Care
Pittsburg, Kansas, 66762
Golden Vision
Sarasota, Florida, 34242
Sacco Eye Group
Vestal, New York, 13850
Dr. David W Ferris and Associates
Warwick, Rhode Island, 02887
Eye Associates of Winter Park
Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Conditions: Refractive Ametropia
Being tested: etafilcon A control lens (1DM), etafilcon A with print and PVP for light eyes (EALE), etafilcon A with print and PVP for dark eyes (EADE)

What participants receive

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

etafilcon A control lens (1DM)Device
Also called 1-DAY ACUVUE MOIST Brand Contact Lenses
A marketed daily disposable contact lens
etafilcon A with print and PVP for light eyes (EALE)Device
A daily disposable contact lens
etafilcon A with print and PVP for dark eyes (EADE)Device
A daily disposable contact lens

Study groups in NCT01484028
Study group	Role	What they receive
EALE/1DM	Other	etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. Receives: Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for light eyes (EALE)
1DM/EALE	Other	etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. Receives: Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for light eyes (EALE)
EADE/1DM	Other	etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. Receives: Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for dark eyes (EADE)
1DM/EADE	Other	etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods. Receives: Device: etafilcon A control lens (1DM); Device: etafilcon A with print and PVP for dark eyes (EADE)

What is being measured

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

Monocular Visual Acuity
Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Measured: Dispensing
Lens Fit Acceptance
The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Measured: Dispensing
Corneal Staining of Grade 3 or 4
Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.
Measured: After 7-9 days of lens wear

Timeline

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

Nov 2011Feb 2012

First posted2 Dec 2011 (estimated)
Study startNov 2011
Primary completionFeb 2012
Study completionFeb 2012

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 AmetropiaStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01484028
Sponsor's protocol ID: CR-005094
Status last verified: May 2015
First submitted: 30 Nov 2011
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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All Refractive Ametropia 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: Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes
ClinicalTrials.gov ID: NCT01484028
Acronym / sponsor ID: CR-005094
Conditions: Refractive Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 2 Dec 2011 (estimated)
Results: Posted 15 Nov 2013

Clinical summary

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

This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
EALE/1DM	Other	Device: etafilcon A control lens (1DM), Device: etafilcon A with print and PVP for light eyes (EALE)etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
1DM/EALE	Other	Device: etafilcon A control lens (1DM), Device: etafilcon A with print and PVP for light eyes (EALE)etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
EADE/1DM	Other	Device: etafilcon A control lens (1DM), Device: etafilcon A with print and PVP for dark eyes (EADE)etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
1DM/EADE	Other	Device: etafilcon A control lens (1DM), Device: etafilcon A with print and PVP for dark eyes (EADE)etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.

Who may qualify

Ages: 18 to 34 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Healthy, female adult, at least 18 years of age, and no more than 34 years of age
The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
Any cylinder power must be: <=0.75D

Key exclusion criteria (14 listed)

Ocular or systemic allergies or disease which might interfere with contact lens wear
Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear
Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear
Any ocular infection

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 A control lens (1DM)Also: 1-DAY ACUVUE MOIST Brand Contact LensesA marketed daily disposable contact lens	Device	1DM/EADE, 1DM/EALE, EADE/1DM, EALE/1DM
etafilcon A with print and PVP for light eyes (EALE)A daily disposable contact lens	Device	1DM/EALE, EALE/1DM
etafilcon A with print and PVP for dark eyes (EADE)A daily disposable contact lens	Device	1DM/EADE, EADE/1DM

Primary outcome

Monocular Visual Acuity
Time frame: Dispensing
Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Lens Fit Acceptance
Time frame: Dispensing
The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Corneal Staining of Grade 3 or 4
Time frame: After 7-9 days of lens wear
Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade >= 3 were reported.

Results and safety

Results posted to the registry on 15 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1DM/EADE	66	66
1DM/EALE	70	67
EADE/1DM	64	64
EALE/1DM	67	66

Primary outcome: Monocular Visual Acuity

Time frame: Dispensing. Mean (Standard Deviation). Unit: LogMAR score

Measure	EADE/EALE n = 264	1-DM n = 265
Value	-0.044 (0.0618)	-0.060 (0.0589)

EADE/EALE vs 1-DM: Least-square mean difference: 0.011 (95% CI 0.004 to 0.017), Mixed Models Analysis

Population analysed: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.

Primary outcome: Lens Fit Acceptance

Time frame: Dispensing. Number (95% Confidence Interval). Unit: % of Eyes

Measure	EADE/EALE n = 264	1-DM n = 265
Value	100 (98.3 to 100)	100 (98.3 to 100)

Population analysed: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.

Primary outcome: Corneal Staining of Grade 3 or 4

Time frame: After 7-9 days of lens wear. Number (95% Confidence Interval). Unit: % of Eyes

Measure	EADE/EALE n = 264	1-DM n = 263
Value	0 (0 to 1.7)	0 (0 to 1.7)

Population analysed: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.

Adverse events

Time frame: Adverse events were recorded when the subjects were exposed to the Investigational lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Etafilcon A With PVP for Dark/Light Eyes	0 of 267 (0%)	0 of 267 (0%)	Not reported
Etafilcon A Control Lenses	0 of 267 (0%)	0 of 267 (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.

15 sites 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 9 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 15 sites in United States. 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 15 Nov 2013). 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?

Monocular Visual Acuity (time frame: Dispensing). 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 NCT01484028.

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.