MyopiaNCT00241280

Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).

A study testing etafilcon A and galyfilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 25 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

Study in the US intended to evaluate the safety and effectiveness of a Johnson \& Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: etafilcon A and galyfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 504 participants
Where: 25 sitesUnited States
Study dates: Sep 2005to Oct 2006
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The subject must be at least 18 years of age.
The subject must read and sign the statement of informed consent and be provided with a copy of the form.
Minimum of 7 days of successful lens wear
Contact lens prescription requiring between -1.00 to -6.00 D spherical power
Less than 1.00 D of astigmatism in either eye

Who cannot join

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Premier Vision
Amarillo, Texas, 79119
Drs. Quinn, Quinn and Associates
Athens, Ohio, 45701
Peter C. Donshik, MD
Bloomfield, Connecticut, 06002
Eyecare Associates
Bloomington, Illinois, 61701
Kenneth A. Young, OD
Brentwood, Tennessee, 37027
Charles Wegman, OD
Carrollton, Texas, 75006
Central Ohio Eyecare
Columbus, Ohio, 43202
Steven S. Grant, OD
Costa Mesa, California, 92626
Lee Rigel
East Lansing, Michigan, 48823
Cole, Cole, and Krohn
Fresno, California, 93704
Drs. Hawks, Besler & Rogers
Gardner, Kansas, 66030
Kenji Hamada, OD
Grants Pass, Oregon, 97526
Dr. Ted Brink and Associates
Jacksonville, Florida, 32256
Wishnow-Sugar Vision Group
Katy, Texas, 77450
Snowy Range Vision Center
Laramie, Wyoming, 82070
Fukai and Associates
Louisville, Colorado, 80027
Scott Jens, OD
Middleton, Wisconsin, 53562
West Hills Vision Center
Moon Township, Pennsylvania, 15108
Clayton Eye Center
Morrow, Georgia, 30260
Gary W. Jerkins, MD
Nashville, Tennessee, 37205
Jack J. Yager, OD
Orlando, Florida, 32803
First Eye Care Plano
Plano, Texas, 75023
Dr. William Bogus
Salt Lake City, Utah, 84106
Univ Missouri at St. Louis, College of Optometry
St Louis, Missouri, 63121
InSight Eyecare
Warrensburg, Missouri, 64093

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About this study

Study in the US intended to evaluate the safety and effectiveness of a Johnson \& Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).

Conditions: Myopia
Being tested: etafilcon A, galyfilcon A
Medical subject headings: Myopia

What participants receive

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

etafilcon ADevice
galyfilcon ADevice

Study groups in NCT00241280
Study group	Role	What they receive
Control	Active comparator	etafilcon A contact lens being worn 7 days/6 nights. Receives: Device: etafilcon A
Test	Experimental	galyfilcon A contact lens being worn 7 days/6 nights. Receives: Device: galyfilcon A

What is being measured

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

Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40
Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
Measured: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
Rate of Contact Lens Related Serious and Significant Events (SSE)
The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.
Measured: Throughout the duration of the study (1 Year)

Timeline

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

Sep 2005Oct 2006

First posted18 Oct 2005 (estimated)
Study startSep 2005
Primary completionOct 2006
Study completionOct 2006

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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 504 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00241280
Sponsor's protocol ID: CR-1480
Status last verified: Feb 2016
First submitted: 14 Oct 2005
Last updated: 24 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

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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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).
ClinicalTrials.gov ID: NCT00241280
Acronym / sponsor ID: CR-1480
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 504 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Oct 2006 (actual)
Study completion: Oct 2006 (actual)
First posted: 18 Oct 2005 (estimated)
Results: Posted 25 Feb 2016

Clinical summary

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

Study in the US intended to evaluate the safety and effectiveness of a Johnson \& Johnson Vision Care Inc, (JJVCI) contact lens for use on an extended-wear basis for up to 7 days (6 nights).

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Device: etafilcon Aetafilcon A contact lens being worn 7 days/6 nights.
Test	Experimental	Device: galyfilcon Agalyfilcon A contact lens being worn 7 days/6 nights.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

The subject must be at least 18 years of age.
The subject must read and sign the statement of informed consent and be provided with a copy of the form.
Minimum of 7 days of successful lens wear
Contact lens prescription requiring between -1.00 to -6.00 D spherical power
Less than 1.00 D of astigmatism in either eye

Key exclusion criteria (1 listed)

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	Device	Control
galyfilcon A	Device	Test

Primary outcome

Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40
Time frame: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
Rate of Contact Lens Related Serious and Significant Events (SSE)
Time frame: Throughout the duration of the study (1 Year)
The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.

Results and safety

Results posted to the registry on 25 Feb 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
Control: Etafilcon A	247	199
Test: Galyfilcon A	254	186

Primary outcome: Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40

Time frame: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks. Number. Unit: Percentage of Subjects Eyes

Measure	Control: Etafilcon A n = 199	Test: Galyfilcon A n = 186
24-Hr. Follow-up, N=396, 370	0	0
1-week Follow-up, N=393, 366	0	0
4-week Follow-up, N=392, 370	0	0
12-week Follow-up, N=388, 370	0	0
24-week Follow-up, N=390, 370	0	.27
36-week Follow-up, N=390 , 365	0	0
52-week Follow-up, N=390, 368	0	0

Population analysed: The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.

Primary outcome: Rate of Contact Lens Related Serious and Significant Events (SSE)

Time frame: Throughout the duration of the study (1 Year). Number. Unit: percentage of Subjects

Measure	Control: Etafilcon A n = 247	Test: Galyfilcon A n = 254
Value	2.4	5.9

Population analysed: All subjects that were dispensed a study lens.

Adverse events

Time frame: Throughout the duration of the Study (1 Year). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control: Etafilcon A	0 of 247 (0%)	23 of 247 (9.3%)	Not reported
Test: Galyfilcon A	1 of 254 (0.4%)	43 of 254 (16.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
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Recruiting
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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.

25 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 and galyfilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 25 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 5 inclusion and 1 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 25 Feb 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?

Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 (time frame: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks). The study lists 2 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 NCT00241280.

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 24 Mar 2016.