MyopiaNCT03701516

Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2

A study testing etafilcon A with novel molding process and etafilcon A with current molding process in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 12 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 a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: etafilcon A with novel molding process and etafilcon A with current molding process
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 268 participants
Where: 12 sitesUnited States
Study dates: 24 Sep 2018to 1 Apr 2019
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lens in both eyes (at least 1 month of daily wear).
The subject must have normal eyes (i.e., no ocular medications or infections of any type).

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The subject's required spherical contact lens prescription must be in the range of -1.00 to -4.50 D in each eye.
The subject's refractive cylinder must be < 0.75 D in each eye.
The subject must have best corrected visual acuity of 20/25 or better in each eye.

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

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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 or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Primary Eyecare Group
Brentwood, Tennessee, 37027
Fleming Island Vision Center
Fleming Island, Florida, 32258
ProCare Vision Centers
Granville, Ohio, 43023
Bartram Eye Clinic
Jacksonville, Florida, 32258
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center
Maitland, Florida, 32751
Total Eye Care, PA
Memphis, Tennessee, 38119
Eyecare Professionals of Powell
Powell, Ohio, 43065
EyeCenter Optometrics
Rocklin, California, 95677
St. Johns Eye Associates
Saint Augustine, Florida, 32092
Boutetourt Eyecare, LLC
Salem, Virginia, 24153
Sacco Eye Group
Vestal, New York, 13850

Other trials in United States

About this study

Conditions: Myopia
Being tested: etafilcon A with novel molding process, etafilcon A with current molding process
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 with novel molding processDevice
TEST Lens
etafilcon A with current molding processDevice
CONTROL Lens

Study groups in NCT03701516
Study group	Role	What they receive
TEST/CONTROL	Experimental	Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence. Receives: Device: etafilcon A with novel molding process; Device: etafilcon A with current molding process
CONTROL/TEST	Experimental	Subjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence. Receives: Device: etafilcon A with novel molding process; Device: etafilcon A with current molding process

What is being measured

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

Overall Comfort Scores
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 1-week Follow-up
Overall Vision Scores
Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 1-week Follow-up

Secondary outcomes (3)

Average Daily Wear Time
Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-week follow-up evaluation. Higher wear times indicate better lens performance. The average wear time was reported for each lens type.
Measured: 1-week Follow-up
LLHC LogMAR Visual Performance
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under low luminance and high contrast conditions (LLHC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
Measured: 1-week Follow-up
HLLC LogMAR Visual Performance
Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under high luminance and low contrast conditions (HLLC) at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1-week follow-up visit. Lower visual performance values indicate better vision. Two measurements were performed for each eye at 1-week follow-up. The average visual performance was reported for each lens type.
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.

24 Sep 20181 Apr 2019

First posted10 Oct 2018
Study start24 Sep 2018
Primary completion1 Apr 2019
Study completion1 Apr 2019

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: 268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03701516
Sponsor's protocol ID: CR-6307
Status last verified: Apr 2022
First submitted: 8 Oct 2018
Last updated: 27 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
ClinicalTrials.gov ID: NCT03701516
Acronym / sponsor ID: CR-6307
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 268 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 24 Sep 2018 (actual)
Primary completion: 1 Apr 2019 (actual)
Study completion: 1 Apr 2019 (actual)
First posted: 10 Oct 2018 (actual)
Results: Posted 27 Apr 2022

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

Arm	Type	Receives
TEST/CONTROL	Experimental	Device: etafilcon A with novel molding process, Device: etafilcon A with current molding processSubjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Test/Control sequence.
CONTROL/TEST	Experimental	Device: etafilcon A with novel molding process, Device: etafilcon A with current molding processSubjects between the ages of 18 and 70 years of age and are habitual wearers of daily disposable contact lens wearers will be randomly assigned to the Control/Test sequence.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

Key exclusion criteria (17 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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 with novel molding processTEST Lens	Device	CONTROL/TEST, TEST/CONTROL
etafilcon A with current molding processCONTROL Lens	Device	CONTROL/TEST, TEST/CONTROL

Primary outcome

Overall Comfort Scores
Time frame: 1-week Follow-up
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Overall Vision Scores
Time frame: 1-week Follow-up
Overall vision was assessed using the CLUE questionnaire. CLUE is a validated PRO questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using IRT follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

3 secondary outcomes

Average Daily Wear Time
Time frame: 1-week Follow-up
LLHC LogMAR Visual Performance
Time frame: 1-week Follow-up
HLLC LogMAR Visual Performance
Time frame: 1-week Follow-up

Results and safety

Results posted to the registry on 27 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test/Control	131	127
Control/Test	132	127

Primary outcome: Overall Comfort Scores

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

Measure	Test n = 237	Control n = 237
Value	59.9 (24.21)	60.8 (24.69)

Test vs Control: Posterior Mean Difference: -0.38 (98% CI -4.53 to 3.85), Bayesian repeated measurement model

Population analysed: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

Primary outcome: Overall Vision Scores

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

Measure	Test n = 237	Control n = 237
Value	64.2 (20.06)	66.5 (19.94)

Test vs Control: Posterior Mean Difference: -2.34 (98% CI -5.36 to 0.61), Bayesian repeated measurement model

Population analysed: All subjects who had successfully completed all visits and did not substantially deviate from the protocol.

3 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 263 (0%)	0 of 263 (0%)	0 of 263
Control	0 of 263 (0%)	0 of 263 (0%)	0 of 263

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

12 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 with novel molding process and etafilcon A with current molding process in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 12 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 9 inclusion and 17 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 27 Apr 2022). 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 Scores (time frame: 1-week Follow-up). 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 NCT03701516.

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 27 Apr 2022.