MyopiaTEMPONCT01467557

Daily Disposable Performance of 1•DAY ACUVUE® TruEye™ and 1•DAY ACUVUE® MOIST® With LACREON® TECHNOLOGY

An observational study of Myopia and Hyperopia, run by Johnson & Johnson Vision Care, Inc. at 37 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 is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY. Read more about this study

Who is it for?: Ages 8 years and older
Conditions the study is for: Myopia, Hyperopia
What is being tested?: narafilcon B daily disposable soft contact lenses and etafilcon A daily disposable soft contact lenses
Type of treatment: Medical device
How many people: 1,171 participants
Where: 37 sitesUnited States
Study dates: Oct 2011to Oct 2013
Phase: Observational
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 8 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.

Who may be able to join

Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged >8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses.
The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form.
The registrant must sign the Release of Medical Records in the event of an adverse event in the study.
The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Who cannot join

Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses).
Current participant in an unrelated research study.
Employee or family member of Recruiting Practitioner or Johnson \& Johnson.

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Study site
Amarillo, Texas, 79119
Study site
Belmont, Massachusetts, 02478
Study site
Boca Raton, Florida, 33431-7253
Study site
Boca Raton, Florida, 33432-3938
Study site
Brentwood, Tennessee, 37027-7552
Study site
Cambridge, Massachusetts, 02138
Study site
Campbell, California, 95008
Study site
Charlotte, North Carolina, 28210
Study site
Cleveland, Ohio, 43081
Study site
Dedham, Massachusetts, 02026
Study site
Des Moines, Iowa, 50310
Study site
Fort Lauderdale, Florida, 33316
Study site
Fort Lauderdale, Florida, 33328-2018
Study site
Fullerton, California, 92831-1615
Study site
Gastonia, North Carolina, 28054
Study site
Huntington Beach, California, 92647
Study site
Johnstown, Ohio, 43031
Study site
Lake Hopatcong, New Jersey, 07849
Study site
Los Angeles, California, 90049
Study site
Milwaukee, Wisconsin, 53227
Study site
Mountain View, California, 94041
Study site
New York, New York, 10022
Study site
New York, New York, 10036
Study site
Newport Beach, California, 92660
Study site
North Miami, Florida, 33181
Study site
Pembroke Pines, Florida, 33024
Study site
Roswell, Georgia, 30075
Study site
Salinas, California, 93901
Study site
San Francisco, California, 94103
Study site
San Francisco, California, 94111
Study site
San Francisco, California, 94158
Study site
San Jose, California, 95131
Study site
Shreveport, Louisiana, 71105
Study site
Sunnyvale, California, 94086
Study site
Washington D.C., District of Columbia, 20016
Study site
Wellington, Florida, 33414
Study site
Westerville, Ohio, 43081

Other trials in United States

About this study

Official title: 1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study

This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.

Conditions: Myopia, Hyperopia
Being tested: narafilcon B daily disposable soft contact lenses, etafilcon A daily disposable soft contact lenses
Keywords: adverse events
Medical subject headings: Myopia, Hyperopia

What participants receive

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

narafilcon B daily disposable soft contact lensesDevice
Also called 1-Day ACUVUE TruEye
daily disposable soft contact lenses
etafilcon A daily disposable soft contact lensesDevice
Also called 1-Day ACUVUE MOIST
daily disposable soft contact lenses

Study groups in NCT01467557
Study group	Role	What they receive
1-Day ACUVUE TruEye contact lens users		1-Day ACUVUE TruEye contact lens users Receives: Device: narafilcon B daily disposable soft contact lenses
1-Day ACUVUE MOIST contact lens users		1-Day ACUVUE MOIST contact lens users Receives: Device: etafilcon A daily disposable soft contact lenses

What is being measured

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

Incidence of Adverse Events
Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.
Measured: Self-report at 2 Week, 4 Month or 12 Month surveys

Secondary outcomes (1)

Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys
The response set for each question was a 5-level likert scale. Intensity of discomfort, dryness, blurriness were measured with the likert scale from 0(Never Have It) to 5(Very Intense). Frequency of discomfort, dryness, blurry vision, removal of lenses, and eye closure(how often you wanted to close them) were measured with the likert scale from 1(Never) to 5(Constantly). The sum of all responses was recorded for each subject and then the average sum for all subjects was reported. The average can range from 0- 40 (continuous).
Measured: Baseline, 2 Week, 4 Month or 12 Month surveys

Timeline

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

Oct 2011Oct 2013

First posted8 Nov 2011 (estimated)
Study startOct 2011
Primary completionOct 2013
Study completionOct 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.
Publications (2)Papers the sponsor has linked to this study.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01467557
Sponsor's protocol ID: CR-005059
Acronym: TEMPO
Status last verified: Oct 2015
First submitted: 26 Oct 2011
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hickson-Curran SB, Chalmers RL, Keay L, Gleason W. Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry. Eye Contact Lens. 2017 Sep;43(5):313-317. doi: 10.1097/ICL.0000000000000271.
PubMed 27243356
Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582.
PubMed 25574042

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

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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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
Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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: 1•DAY ACUVUE® TruEye™ Brand Contact Lenses & 1•DAY ACUVUE® MOIST® Brand Contact Lenses With LACREON® TECHNOLOGY Daily Disposable Performance Overview Registry -TEMPO Study
ClinicalTrials.gov ID: NCT01467557
Acronym / sponsor ID: TEMPO / CR-005059
Conditions: Myopia, Hyperopia
Keywords: adverse events
Study type: Observational
Recruitment status: Completed
Enrolment: 1,171 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 8 Nov 2011 (estimated)
Results: Posted 15 Sep 2015

Clinical summary

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

This study is an observational registry of patients who have recently been prescribed 1•DAY ACUVUE® TruEye® or 1•DAY ACUVUE® MOIST® Brand Contact Lenses with LACREON® TECHNOLOGY.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
1-Day ACUVUE TruEye contact lens users	–	Device: narafilcon B daily disposable soft contact lenses1-Day ACUVUE TruEye contact lens users
1-Day ACUVUE MOIST contact lens users	–	Device: etafilcon A daily disposable soft contact lenses1-Day ACUVUE MOIST contact lens users

Who may qualify

Ages: 8 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who have recently been fit with 1-Day ACUVUE® TruEye™ or 1- Day ACUVUE® MOIST® daily disposable lenses.

Key inclusion criteria (4 listed)

Wearers of 1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® daily disposable soft contact lenses in both eyes aged >8 years of age who have recently begun use of that lens type and have purchased at least 3 month supply of lenses.
The registrant must read and sign the Informed Consent form. Minor subjects must obtain parental signature of Informed Consent and also sign an Informed Assent Form.
The registrant must sign the Release of Medical Records in the event of an adverse event in the study.
The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Key exclusion criteria (3 listed)

Previously wearing the type of lenses with which they are registering (1•DAY ACUVUE® TruEye™ or 1•DAY ACUVUE® MOIST® Daily Disposable lenses).
Current participant in an unrelated research study.
Employee or family member of Recruiting Practitioner or Johnson \& Johnson.

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
narafilcon B daily disposable soft contact lensesAlso: 1-Day ACUVUE TruEyedaily disposable soft contact lenses	Device	1-Day ACUVUE TruEye contact lens users
etafilcon A daily disposable soft contact lensesAlso: 1-Day ACUVUE MOISTdaily disposable soft contact lenses	Device	1-Day ACUVUE MOIST contact lens users

Primary outcome

Incidence of Adverse Events
Time frame: Self-report at 2 Week, 4 Month or 12 Month surveys
Adverse events were reported by subjects via the electronic surveys if they responded "yes" to the question "Since we last contacted you, have you experienced a red or painful eye that required a visit to an eye doctor or emergency room?". Consensus diagnosis was made after review of clinical records by Adjudication Panel.

1 secondary outcome

Change in 8-item Contact Lens Dry Eye Questionnaire Score From Baseline to 2 Week, 4 Month and 12 Month Surveys
Time frame: Baseline, 2 Week, 4 Month or 12 Month surveys

Results and safety

Results posted to the registry on 15 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1-Day ACUVUE TruEye Contact Lens Users	601	502
1-Day ACUVUE MOIST Contact Lens Users	570	463

Primary outcome: Incidence of Adverse Events

Time frame: Self-report at 2 Week, 4 Month or 12 Month surveys. Number. Unit: participants

Measure	1-Day ACUVUE TruEye Contact Lens Users n = 601	1-Day ACUVUE MOIST Contact Lens Users n = 570
Corneal Infiltrative Events	2	0
CL-Related Adverse Events with Office Visit	8	3
Not CL-Related Adverse Events with Office Visit	5	2
"Yes" to Red Eye Question, but no Office Visit	6	5

Population analysed: The analysis population consisted of subjects that were enrolled into this study. (i.e subjects that met all study eligibility criteria)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1-Day ACUVUE TruEye Contact Lens Users	0 of 601 (0%)	0 of 601 (0%)	Not reported
1-Day ACUVUE MOIST Contact Lens Users	0 of 570 (0%)	0 of 570 (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.
Derived from this study: PubMed 27243356Hickson-Curran SB, Chalmers RL, Keay L, Gleason W. Patient-Reported Wearing Experience From Hydrogel Daily Disposable Wearers Older Than 40 Years From the TEMPO Registry. Eye Contact Lens. 2017 Sep;43(5):313-317. doi: 10.1097/ICL.0000000000000271.
Derived from this study: PubMed 25574042Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of adverse events with hydrogel and silicone hydrogel daily disposable lenses in a large postmarket surveillance registry: the TEMPO Registry. Invest Ophthalmol Vis Sci. 2015 Jan 8;56(1):654-63. doi: 10.1167/iovs.14-15582.

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
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Myopia and Hyperopia, run by Johnson & Johnson Vision Care, Inc. at 37 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 4 inclusion and 3 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 37 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 Sep 2015). 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?

Incidence of Adverse Events (time frame: Self-report at 2 Week, 4 Month or 12 Month surveys). 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 NCT01467557, which also lists 2 linked publications.

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.