MyopiaNCT02061592

Evaluation of Etafilcon A Daily Disposable Lenses

A study testing etafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 7 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

To evaluate the clinical performance of daily disposable etafilcon A lenses. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Myopia
What is being tested?: etafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 7 sitesUnited States
Study dates: Jan 2014to Mar 2014
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 70 years
All sexes
No healthy volunteers
Adult, Older 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.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 18 and not more than 70 years of age.
The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
The subject must have best corrected visual acuity of 20/25 or better in each eye.
The subject's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.

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The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
The subject must self-report their race as Asian
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

Who cannot join

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.).
Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

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Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Monovision or multi-focal contact lens correction.
Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
History of binocular vision abnormality or strabismus.
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
Suspicion of or recent history of alcohol or substance abuse.
History of serious mental illness.
History of seizures.
Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Study site
‘Aiea, Hawaii
Study site
Honolulu, Hawaii
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kahului, Hawaii
Study site
New York, New York
Study site
Waipahu, Hawaii

Other trials in United States

About this study

Official title: Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Conditions: Myopia
Being tested: etafilcon 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
etafilcon ADevice

Study groups in NCT02061592
Study group	Role	What they receive
Etafilcon A Control Lens	Active comparator	etafilcon A Receives: Device: etafilcon A
Etafilcon A Test Lens	Experimental	etafilcon A Receives: Device: etafilcon A

What is being measured

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

Overall Comfort
Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Measured: 1-week follow-up
Overall Vision
Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Measured: 1- week Follow-up
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Measured: 1-week follow-up
Monocular logMar Visual Acuity - Standard Low Contrast Bright
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Measured: 1- week Follow-up

Timeline

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

Jan 2014Mar 2014

First posted13 Feb 2014 (estimated)
Study startJan 2014
Primary completionMar 2014
Study completionMar 2014

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02061592
Sponsor's protocol ID: CR-5553
Status last verified: Aug 2015
First submitted: 7 Feb 2014
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 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: Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses
ClinicalTrials.gov ID: NCT02061592
Acronym / sponsor ID: CR-5553
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 13 Feb 2014 (estimated)
Results: Posted 7 Aug 2015

Clinical summary

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

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Etafilcon A Control Lens	Active comparator	Device: etafilcon Aetafilcon A
Etafilcon A Test Lens	Experimental	Device: etafilcon Aetafilcon A

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject must be at least 18 and not more than 70 years of age.
The subject's refractive cylinder must be < 1.00 Diopters (D) in each eye.
The subject must have best corrected visual acuity of 20/25 or better in each eye.

Key exclusion criteria (16 listed)

Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in-situ keratomileusis (LASIK), etc.).

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	Etafilcon A Control Lens
etafilcon A	Device	Etafilcon A Test Lens

Primary outcome

Overall Comfort
Time frame: 1-week follow-up
Subjective assessment of comfort was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens- wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Overall Vision
Time frame: 1- week Follow-up
Subjective assessment of vision was performed using the Contact Lens User Experience TM (CLUE) questionnaire. CLUE was a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact lens-wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicated a more favorable/positive response with a range of 0 to 120.
Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim
Time frame: 1-week follow-up
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision.Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.
Monocular logMar Visual Acuity - Standard Low Contrast Bright
Time frame: 1- week Follow-up
LogMar visual acuity within each eye was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts. A LogMar acuity value of 0 indicates that a subject has 20/20 vision. Positive LogMar acuity values indicate worsened vision while negative LogMar acuity values would indicated improved vision.

Results and safety

Results posted to the registry on 7 Aug 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
Control/Test	66	64
Test/Control	62	62

Primary outcome: Overall Comfort

Time frame: 1-week follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Control n = 113	Test n = 113
Value	60.1 (18.47)	43.6 (20.19)

Population analysed: Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.

Primary outcome: Overall Vision

Time frame: 1- week Follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Control n = 113	Test n = 113
Value	64.9 (18.23)	58.0 (19.51)

Population analysed: Analysis population consisted of subjects that successfully completed the study visits without any major protocol deviations.

Primary outcome: Monocular Logarithm of the Minimum Angle of Resolution (logMAR) Visual Acuity - Standard High Contrast Dim

Time frame: 1-week follow-up. Mean (Standard Deviation). Unit: LogMar

Measure	Control n = 100	Test n = 100
Value	0.030 (0.088)	0.020 (0.085)

Population analysed: Consisted of subjects that successfully completed all study visits without any major protocol deviations. 13 Subjects were not included in the analysis population due to study procedures not properly followed from one of the investigational sites where the measured results were not collected in the lighting conditions described in the protocol.

Primary outcome: Monocular logMar Visual Acuity - Standard Low Contrast Bright

Time frame: 1- week Follow-up. Mean (Standard Deviation). Unit: LogMar

Measure	Control n = 113	Test n = 113
Value	0.060 (0.083)	0.050 (0.079)

Population analysed: Analysis population consisted of subjects that successfully completed all study visits without any major protocol deviations.

Adverse events

Time frame: One week for each intervention. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 113 (0%)	0 of 113 (0%)	Not reported
Test	0 of 113 (0%)	0 of 113 (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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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.

7 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 in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 7 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 10 inclusion and 16 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 7 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 7 Aug 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?

Overall Comfort (time frame: 1-week follow-up). The study lists 4 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 NCT02061592.

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.