Visual AcuityNCT04885296

Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

A study testing TRP-200 and JJVC Marketed Contact Lens in people with Visual Acuity, 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 is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker. Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: TRP-200 and JJVC Marketed Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 12 sitesUnited States
Study dates: 10 May 2021to 9 Aug 2021
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 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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.
Be between 18 and 39 (inclusive) years of age at the time of screening.
By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.

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The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (except -5.00 D) in both eyes.
The subject's refractive cylinder must be 1.00 D or less.
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:
Be currently pregnant or lactating.
Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear modality.

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Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
Have a history of binocular vision abnormality or strabismus.
Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Have 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.
Have any ocular infection.
Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Birmingham Vision Care
Bloomfield Township, Michigan, 48301
Dr. Debbie H. Kim, OD
Closter, New Jersey, 07624
Gulf Coast Vision Center, Inc.
Houston, Texas, 77054
Dr. James Weber & Associates, PA
Jacksonville, Florida, 32205
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, LLC
Memphis, Tennessee, 38111
Flora Chen Poveda, OD, PA
Orange Park, Florida, 32073
Visual Eyes
Roswell, Georgia, 30075
Botetourt Eyecare, LLC
Salem, Virginia, 24153
Tallahassee Eye Center
Tallahassee, Florida, 32308
Frazier Vision, Inc.
Tyler, Texas, 75703
Professional Vision Care, Inc.
Westerville, Ohio, 43081

Other trials in United States

About this study

This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.

Conditions: Visual Acuity
Being tested: TRP-200, JJVC Marketed Contact Lens

What participants receive

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

TRP-200Device
Also called TEST Lens
JJVC Investigational Contact Lens
JJVC Marketed Contact LensDevice
Also called CONTROL Lens
ACUVUE Oasys 1-Day

Study groups in NCT04885296
Study group	Role	What they receive
Test/Control	Experimental	Eligible subjects will be randomized into one of two possible lens wear sequences, Test/Control. Receives: Device: TRP-200; Device: JJVC Marketed Contact Lens
Control/Test	Experimental	Eligible subjects will be randomized into one of two possible lens wear sequences, Control/Test. Receives: Device: TRP-200; Device: JJVC Marketed Contact Lens

What is being measured

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

Overall Quality of Vision Score
Overall quality of vision scores were 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 CLUE vision score for each lens type was reported.
Measured: 2-Week Follow-up

Secondary outcomes (2)

Overall Comfort Scores
Overall comfort scores were 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 CLUE comfort score for each lens type was reported.
Measured: 2-Week Follow-up
Overall Handling Scores
Overall handling scores were 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 CLUE handling score for each lens type 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.

10 May 20219 Aug 2021

First posted13 May 2021
Study start10 May 2021
Primary completion9 Aug 2021
Study completion9 Aug 2021

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: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04885296
Sponsor's protocol ID: CR-6437
Status last verified: Aug 2022
First submitted: 10 May 2021
Last updated: 1 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

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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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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Active, not recruitingPhase 2
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Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
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Not yet recruitingPhase 3
Study With Batten-1 (Miglustat Liquid Formulation) to Treat Ceroid Lipofuscinosis Neuronal 3 (CLN3) Disease
CLN3
Active, not recruiting
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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Prototype Lenses With Experimental UV/HEV Blocker
ClinicalTrials.gov ID: NCT04885296
Acronym / sponsor ID: CR-6437
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 10 May 2021 (actual)
Primary completion: 9 Aug 2021 (actual)
Study completion: 9 Aug 2021 (actual)
First posted: 13 May 2021 (actual)
Results: Posted 1 Sep 2022

Clinical summary

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

This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.

Study design

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

Arm	Type	Receives
Test/Control	Experimental	Device: TRP-200, Device: JJVC Marketed Contact LensEligible subjects will be randomized into one of two possible lens wear sequences, Test/Control.
Control/Test	Experimental	Device: TRP-200, Device: JJVC Marketed Contact LensEligible subjects will be randomized into one of two possible lens wear sequences, Control/Test.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (14 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
TRP-200Also: TEST LensJJVC Investigational Contact Lens	Device	Control/Test, Test/Control
JJVC Marketed Contact LensAlso: CONTROL LensACUVUE Oasys 1-Day	Device	Control/Test, Test/Control

Primary outcome

Overall Quality of Vision Score
Time frame: 2-Week Follow-up
Overall quality of vision scores were 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 CLUE vision score for each lens type was reported.

2 secondary outcomes

Overall Comfort Scores
Time frame: 2-Week Follow-up
Overall Handling Scores
Time frame: 2-Week Follow-up

Results and safety

Results posted to the registry on 1 Sep 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
Control (Senofilcon A C3) /Test (Senofilcon A C3)	117	112
Test (Senofilcon A C3) /Control (Senofilcon A C3)	110	108

Primary outcome: Overall Quality of Vision Score

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

Measure	Test (Senofilcon A C3) n = 216	Control (Senofilcon A C3) n = 216
Value	69.3 (20.84)	69.0 (22.12)

Test (Senofilcon A C3) vs Control (Senofilcon A C3): LS Mean Difference: 0.4 (95% CI -2.2 to 3.0), Linear Mixed Model

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the duration of the study; The study duration for each subject was approximately 26 to 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control (Senofilcon A C3)	0 of 227 (0%)	0 of 227 (0%)	0 of 227
Test (Senofilcon A C3)	0 of 227 (0%)	0 of 227 (0%)	0 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Related trials for Visual Acuity

RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 3
Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Radiation Retinopathy, Visual Impairment
Not yet recruitingPhase 3
Study With Batten-1 (Miglustat Liquid Formulation) to Treat Ceroid Lipofuscinosis Neuronal 3 (CLN3) Disease
CLN3
Active, not recruiting
Mean Visual Acuity Changes Following Five Injections of Aflibercept
Diabetic Macular Edema

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.

Johnson & Johnson Vision Care, Inc. Clinical Trial study director

Johnson & Johnson Vision Care, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing TRP-200 and JJVC Marketed Contact Lens in people with Visual Acuity, 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 14 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 1 Sep 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 1 Sep 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 Quality of Vision Score (time frame: 2-Week Follow-up). 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 NCT04885296.

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 1 Sep 2022.