MyopiaNCT01669629

Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear

A study testing delefilcon A and etafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 10 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 is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Myopia
What is being tested?: delefilcon A and etafilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 183 participants
Where: 10 sitesUnited States
Study dates: Aug 2012to Nov 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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
The subject must be a current successful soft contact lens wearer in both eyes
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye.

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The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.
The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
The subject must require a visual correction in both eyes (no monofit or monovision allowed).
The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection (including blepharitis/meibomitis).
No conjunctival abnormality or infection.
No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
No other active ocular disease.

Who cannot join

Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Clinically significant (Grade 3 or 4) 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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Pregnancy or lactation.
No extended wear in the last 3 months.
Diabetes.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
Employee or family member of the staff of the investigational site.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Study site
Bartlett, Tennessee, 38134
Study site
Blue Springs, Missouri, 64015
Study site
Bridgeport, Connecticut, 06610
Study site
Chamberlain, South Dakota, 57325
Study site
Kittanning, Pennsylvania, 16201
Study site
Little Rock, Arkansas, 72116
Study site
Raleigh, North Carolina, 27615
Study site
Tampa, Florida, 33625
Study site
Vestal, New York, 13850
Study site
Warwick, Rhode Island, 02888

Other trials in United States

About this study

Conditions: Myopia
Being tested: delefilcon A, 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.

delefilcon ADevice
Daily wear soft contact lens for bilateral distance vision correction use.
etafilcon ADevice
Daily wear soft contact lens for bilateral distance vision correction use.

Study groups in NCT01669629
Study group	Role	What they receive
Delefilcon A/ Etafilcon A	Experimental	6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear Receives: Device: delefilcon A; Device: etafilcon A
Etafilcon A / Delefilcon A	Experimental	6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear Receives: Device: delefilcon A; Device: etafilcon A

What is being measured

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

Subject Reported Ease of Removal
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.
Measured: 6-10 Days

Secondary outcomes (4)

Subject Reported Overall Comfort
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Summary is reported as an aggregate of Excellent/Very Good at their 1-week visit.
Measured: 6-10 Days
Subject Reported Overall Vision
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant using an aggregate summary of excellent/very good at their 1-week visit.
Measured: 6-10 Days
Binocular Snellen Visual Acuity
Snellen visual acuity percentage of eyes with a visual acuity of eyesight testing at a 20/20 level or better by eye.
Measured: 6-10 Days
Overall Corneal Staining
Proportion of subjects that have corneal staining on the 0-4 the NEI/Industry Workshop guidelines scale, measured by eye.
Grade 1 or higher is reported as a percentage of total eyes.
Measured: 6-10 Days

Timeline

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

Aug 2012Nov 2012

First posted21 Aug 2012 (estimated)
Study startAug 2012
Primary completionNov 2012
Study completionNov 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 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01669629
Sponsor's protocol ID: CR-005199
Status last verified: Mar 2016
First submitted: 16 Aug 2012
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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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: Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
ClinicalTrials.gov ID: NCT01669629
Acronym / sponsor ID: CR-005199
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 21 Aug 2012 (estimated)
Results: Posted 4 Jun 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
Delefilcon A/ Etafilcon A	Experimental	Device: delefilcon A, Device: etafilcon A6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear
Etafilcon A / Delefilcon A	Experimental	Device: delefilcon A, Device: etafilcon A6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (15 listed)

The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
The subject must be a current successful soft contact lens wearer in both eyes
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Key exclusion criteria (11 listed)

Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
Clinically significant (Grade 3 or 4) 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
delefilcon ADaily wear soft contact lens for bilateral distance vision correction use.	Device	Delefilcon A/ Etafilcon A, Etafilcon A / Delefilcon A
etafilcon ADaily wear soft contact lens for bilateral distance vision correction use.	Device	Delefilcon A/ Etafilcon A, Etafilcon A / Delefilcon A

Primary outcome

Subject Reported Ease of Removal
Time frame: 6-10 Days
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.

4 secondary outcomes

Subject Reported Overall Comfort
Time frame: 6-10 Days
Subject Reported Overall Vision
Time frame: 6-10 Days
Binocular Snellen Visual Acuity
Time frame: 6-10 Days
Overall Corneal Staining
Time frame: 6-10 Days

Results and safety

Results posted to the registry on 4 Jun 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
Delefilcon A \ Etafilcon A	92	91
Etafilcon A \ Delefilcon A	91	89

Primary outcome: Subject Reported Ease of Removal

Time frame: 6-10 Days. Number. Unit: percentage of participants

Measure	Delefilcon A n = 180	Etafilcon A n = 180
Value	47.2	75.6

Population analysed: Subjects analyzed were those who enrolled, randomized, and completed the study per protocol.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study. Approximately 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 90 (0%)	0 of 90 (0%)	Not reported
Etafilcon A	0 of 90 (0%)	0 of 90 (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
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing delefilcon A and etafilcon A in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 10 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 15 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 10 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 4 Jun 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?

Subject Reported Ease of Removal (time frame: 6-10 Days). 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 NCT01669629.

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.