MyopiaNCT01180777

Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP)

A study testing etafilcon A (A), etafilcon A (B) and etafilcon A (C) in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 6 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

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP). Read more about this study

Who is it for?: Ages 18 to 40 years, women only
Conditions the study is for: Myopia
What is being tested?: etafilcon A (A), etafilcon A (B) and etafilcon A (C)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 6 sitesUnited States
Study dates: 1 Jul 2010to 1 Aug 2010
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 40 years
Women only
No healthy volunteers
Adult

Who may be able to join

The subject must be at least 18 years of age and less than 40 years of age.
The subject must be a light eye Caucasian female habitual soft contact lens wearer.
The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.

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Any cylinder power must be ≤ -0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
The subject must have normal eyes (no ocular medications or ocular infection of any type).
The subject must read and sign the Statement of Informed Consent.
The subject 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 or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, 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 - 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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Study site
Cupertino, California, 95014
Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32256
Study site
Los Angeles, California, 90049
Study site
Orlando, Florida, 32792
Study site
San Jose, California, 95131

Other trials in United States

About this study

Official title: Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

Conditions: Myopia
Being tested: etafilcon A (A), etafilcon A (B), etafilcon A (C)
Medical subject headings: Myopia

What participants receive

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

etafilcon A (A)Device
Also called printed etafilcon A Lens with PVP (A)
Daily wear contact lens
etafilcon A (B)Device
Also called printed etafilcon A Lens PVP (B)
Daily wear contact lens
etafilcon A (C)Device
Also called printed etafilcon A Lens PVP (C)
Daily wear contact lens

Study groups in NCT01180777
Study group	Role	What they receive
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)	Other	Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear. Receives: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)	Other	Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear. Receives: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)	Other	Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear. Receives: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)	Other	Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear. Receives: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)	Other	Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear. Receives: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)	Other	Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear. Receives: Device: etafilcon A (A); Device: etafilcon A (B); Device: etafilcon A (C)

What is being measured

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

Lens Fit Acceptance
Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.
Measured: 10-15 minutes post lens fit

Secondary outcomes (2)

Binocular Snellen Visual Acuity (VA)
Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.
Measured: 10-15 minutes post lens fit
Corneal Staining
Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.
Measured: After 6-9 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.

1 Jul 20101 Aug 2010

First posted12 Aug 2010 (estimated)
Study start1 Jul 2010
Primary completion1 Aug 2010
Study completion1 Aug 2010

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 MyopiaStudies 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: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01180777
Sponsor's protocol ID: CR-1579AP
Status last verified: Aug 2017
First submitted: 3 Aug 2010
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
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All Myopia 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: Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses
ClinicalTrials.gov ID: NCT01180777
Acronym / sponsor ID: CR-1579AP
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jul 2010 (actual)
Primary completion: 1 Aug 2010 (actual)
Study completion: 1 Aug 2010 (actual)
First posted: 12 Aug 2010 (estimated)
Results: Posted 5 Mar 2014

Clinical summary

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

The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)	Other	Device: etafilcon A (A), Device: etafilcon A (B), Device: etafilcon A (C)Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)	Other	Device: etafilcon A (A), Device: etafilcon A (B), Device: etafilcon A (C)Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)	Other	Device: etafilcon A (A), Device: etafilcon A (B), Device: etafilcon A (C)Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)	Other	Device: etafilcon A (A), Device: etafilcon A (B), Device: etafilcon A (C)Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)	Other	Device: etafilcon A (A), Device: etafilcon A (B), Device: etafilcon A (C)Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)	Other	Device: etafilcon A (A), Device: etafilcon A (B), Device: etafilcon A (C)Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

The subject must be at least 18 years of age and less than 40 years of age.
The subject must be a light eye Caucasian female habitual soft contact lens wearer.
The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.

Key exclusion criteria (11 listed)

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, 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 (A)Also: printed etafilcon A Lens with PVP (A)Daily wear contact lens	Device	etafilcon A (A)/etafilcon A (B)/etafilcon A (C), etafilcon A (A)/etafilcon A (C)/etafilcon A (B), etafilcon A (B)/etafilcon A (A)/etafilcon A (C), etafilcon A (B)/etafilcon A (C)/etafilcon A (A), etafilcon A (C)/etafilcon A (A)/etafilcon A (B), etafilcon A (C)/etafilcon A (B)/etafilcon A (A)
etafilcon A (B)Also: printed etafilcon A Lens PVP (B)Daily wear contact lens	Device	etafilcon A (A)/etafilcon A (B)/etafilcon A (C), etafilcon A (A)/etafilcon A (C)/etafilcon A (B), etafilcon A (B)/etafilcon A (A)/etafilcon A (C), etafilcon A (B)/etafilcon A (C)/etafilcon A (A), etafilcon A (C)/etafilcon A (A)/etafilcon A (B), etafilcon A (C)/etafilcon A (B)/etafilcon A (A)
etafilcon A (C)Also: printed etafilcon A Lens PVP (C)Daily wear contact lens	Device	etafilcon A (A)/etafilcon A (B)/etafilcon A (C), etafilcon A (A)/etafilcon A (C)/etafilcon A (B), etafilcon A (B)/etafilcon A (A)/etafilcon A (C), etafilcon A (B)/etafilcon A (C)/etafilcon A (A), etafilcon A (C)/etafilcon A (A)/etafilcon A (B), etafilcon A (C)/etafilcon A (B)/etafilcon A (A)

Primary outcome

Lens Fit Acceptance
Time frame: 10-15 minutes post lens fit
Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.

2 secondary outcomes

Binocular Snellen Visual Acuity (VA)
Time frame: 10-15 minutes post lens fit
Corneal Staining
Time frame: After 6-9 days of lens wear

Results and safety

Results posted to the registry on 5 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects	92	80

Primary outcome: Lens Fit Acceptance

Time frame: 10-15 minutes post lens fit. Number. Unit: eyes

Measure	Etafilcon A (A) n = 80	Etafilcon A (B) n = 80	Etafilcon A (C) n = 80
Acceptable	158	158	157
Unacceptable	0	2	0

Population analysed: All subjects who successfully completed the study.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	1 of 95 (1.1%)	0 of 95 (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.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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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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Clinical Performance and Outcomes After Toric Lens Transition
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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A (A), etafilcon A (B) and etafilcon A (C) in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 6 sites in United States.

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 11 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 6 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 5 Mar 2014). 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?

Lens Fit Acceptance (time frame: 10-15 minutes post lens fit). 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 NCT01180777.

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.