Visual AcuityNCT03228212

Evaluation of Approved and Investigational Contact Lenses

A study testing TEST in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 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

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: TEST
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 5 sitesUnited States
Study dates: 14 Jul 2017to 18 Sep 2017
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 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Potential subjects must satisfy all of the following inclusion criteria to be enrolled in the study:
The subject must read and sign the Informed Consent form.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Healthy adult males or females age ≥18 and ≤49 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopter (D).
The subject's refractive cylinder must be ≤ 1.00D in each eye.

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The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
Subjects must own a wearable pair of spectacles.
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week
The subject must have normal eyes (i.e., no ocular medications or infections of any type).

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, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g., Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.
Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.).

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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.
Any known hypersensitivity or allergic reaction to Optifree®PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution
Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Toric, extended wear, monovision or multi-focal contact lens correction.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
History of binocular vision abnormality or strabismus.
Employee, relative or friends of employees of any ophthalmic company, or investigational clinic (e.g., Investigator, Coordinator, Technician).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

VisionCare Associates
East Lansing, Michigan, 48823
Dr. James Weber & Associates, PA
Jacksonville, Florida, 32205
Vue Optical Boutique
Jacksonville, Florida, 32250
Pickens Family Eye Care
Pickens, South Carolina, 29671
William J. Bogus, OD
Salt Lake City, Utah, 84106

Other trials in United States

About this study

This study is a randomized, 5-visit, partial subject masked, 2x3 bilateral crossover, dispensing clinical trial. During the study, each test article will be worn in a daily wear modality for at least 6 hours per day and 5 days per week for approximately 2 weeks each. The subject will wear either the Test or Control article twice and the other study article once. The primary objective of this study is to demonstrate that the Test lens works as well, if not better compared to the Control lens with respect to CLUE (Contact Lens User Experience) comfort, Slit Lamp findings, and Distance Monocular logMAR Visual Acuity. This study will also aim to show acceptable lens fit for subjects wearing the Test lens.

Conditions: Visual Acuity
Being tested: CONTROL, TEST

What participants receive

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

CONTROLDevice
ACUVUE OASYS
TESTDevice
senofilcon A with new UV blocker

Study groups in NCT03228212
Study group	Role	What they receive
TEST/CONTROL/CONTROL	Experimental	Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (TEST/CONTROL/CONTROL) Receives: Device: CONTROL; Device: TEST
CONTROL/TEST/TEST	Experimental	Enrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (CONTROL/TEST/TEST) Receives: Device: CONTROL; Device: TEST

What is being measured

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

Overall Comfort
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. The average comfort score from the 3 study periods was reported.
Measured: 2-Week Follow-up
Distance Monocular LogMAR Visual Acuity
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.
Measured: 2-Week Follow-up
Contact Lens Fitting Acceptance Rate
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.
Measured: Up to 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.
Measured: Up to 2-Week Follow-up

Secondary outcomes (2)

Overall Quality of Vision
Overall quality of vision 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. The average vision score from the 3 study periods was reported.
Measured: 2-Week Follow-up
Overall Handling
Overall Handling 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. The average handling score from the 3 study periods was reported.
Measured: 2-Week Follow-up

Timeline

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

14 Jul 201718 Sep 2017

First posted24 Jul 2017
Study start14 Jul 2017
Primary completion18 Sep 2017
Study completion18 Sep 2017

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 Visual AcuityStudies 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: Single blind
Who is masked: Participant
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03228212
Sponsor's protocol ID: CR-5960
Status last verified: Dec 2018
First submitted: 20 Jul 2017
Last updated: 13 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

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 Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Approved and Investigational Contact Lenses
ClinicalTrials.gov ID: NCT03228212
Acronym / sponsor ID: CR-5960
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 14 Jul 2017 (actual)
Primary completion: 18 Sep 2017 (actual)
Study completion: 18 Sep 2017 (actual)
First posted: 24 Jul 2017 (actual)
Results: Posted 13 Dec 2018

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: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
TEST/CONTROL/CONTROL	Experimental	Device: CONTROL, Device: TESTEnrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (TEST/CONTROL/CONTROL)
CONTROL/TEST/TEST	Experimental	Device: CONTROL, Device: TESTEnrolled subjects will be habitual wearers of spherical contact lenses between the ages of 18 and 49 years old. Subjects will wear the Test and Control contact lenses bilaterally for approximately 2 weeks each on a daily wear basis. Subjects will be randomly assigned to one of the two lens wear sequences, (CONTROL/TEST/TEST)

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (15 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
CONTROLACUVUE OASYS	Device	CONTROL/TEST/TEST, TEST/CONTROL/CONTROL
TESTsenofilcon A with new UV blocker	Device	CONTROL/TEST/TEST, TEST/CONTROL/CONTROL

Primary outcome

Overall Comfort
Time frame: 2-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. The average comfort score from the 3 study periods was reported.
Distance Monocular LogMAR Visual Acuity
Time frame: 2-Week Follow-up
Distance Monocular LogMAR visual acuity was assessed at 4 meters using an ETDRS chart at the 2-week follow-up for each subject eye during each of the three study periods. The average visual acuity for each lens type from the 3 study periods was reported.
Contact Lens Fitting Acceptance Rate
Time frame: Up to 2-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope at post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens. The lens fit acceptance rate for both post lens fitting at the 2-week follow-up was reported for each lens type.
Number of Grade 3 or Higher Slit Lamp Findings
Time frame: Up to 2-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 2-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by lens was reported.

2 secondary outcomes

Overall Quality of Vision
Time frame: 2-Week Follow-up
Overall Handling
Time frame: 2-Week Follow-up

Results and safety

Results posted to the registry on 13 Dec 2018, 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/Control	65	64
Control/Test/Test	65	64

Primary outcome: Overall Comfort

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Test n = 121	Control n = 121
Value	67.509 (23.8724)	61.185 (24.2024)

Test vs Control: Mean Difference (Final Values): 5.1 (95% CI 1.16 to 9.09), Bayesian multivariate normal random-effe

Population analysed: All subjects that completed all study visits without a major protocol deviation.

Primary outcome: Distance Monocular LogMAR Visual Acuity

Time frame: 2-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Test n = 65	Control n = 65
Value	-0.095 (0.0831)	-0.075 (0.0806)

Test vs Control: Mean Difference (Final Values): 0.02 (95% CI 0.01 to 0.03), Bayesian multivariate normal random-effe

Population analysed: All subjects that completed all study visits without a major protocol deviation.

Primary outcome: Contact Lens Fitting Acceptance Rate

Time frame: Up to 2-Week Follow-up. Number. Unit: proportion of eyes

Measure	Test n = 65	Control n = 65
Value	1	1

Test: proportion: 0.992 (95% CI 0.96 to 1), Bayesian Methods

Population analysed: Subjects that completed all study visits.

Primary outcome: Number of Grade 3 or Higher Slit Lamp Findings

Time frame: Up to 2-Week Follow-up. Number. Unit: Slit Lamp Finding

Measure	Test n = 65	Control n = 65
Value	0	1

Test vs Control: Mean Difference (Final Values): -0.0043 (95% CI -0.0237 to 0.0129), Bayesian beta-binomial model

Population analysed: Subjects that were dispensed at least one study lens.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the entire duration of the study. Approximately 6 weeks per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 130 (0%)	0 of 130 (0%)	0 of 130
Control	0 of 130 (0%)	0 of 130 (0%)	0 of 130

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing TEST in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 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 11 inclusion and 15 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 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 13 Dec 2018). 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: 2-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 NCT03228212.

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 13 Dec 2018.