AzTrials
AzTrials

Visual AcuityNCT03707821

Design Validation of Senofilcon A With New UV-blocking Additive

A study testing senofilcon A TEST Lens in people with Visual Acuity, 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
Search all trials

Trial summary

This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
senofilcon A TEST Lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
253 participants
Where
10 sitesUnited States
Study dates
1 Oct 2018to 1 Nov 2018
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 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.
  • Between 18 and 49 (inclusive) years of age at the time of informed consent.
  • Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
  • The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
Show all 11Show fewer
  • Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
  • Subjects must own a wearable pair of distance spectacles.
  • The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
  • The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.
  • The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 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 active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
  • Subjects taking suspect oral medications for less than one year.
  • Any prescribed or over the counter (OTC) ocular medication.
  • Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
Show all 16Show fewer
  • Toric, extended wear, monovision or multi-focal contact lens correction.
  • Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
  • 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.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  • Binocular vision abnormality or strabismus by self-report or prior medical history.
  • History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
  • Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
  • Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
  • Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Eyecare Associates LLP

    Bloomington, Illinois, 61701

  • James T. Fujimoto, OD

    Cupertino, California, 95014

  • ProCare Vision Centers

    Granville, Ohio, 43023

  • Maitland Vision Center

    Maitland, Florida, 32751

  • Bradley Hines, OD

    Memphis, Tennessee, 38111

  • Ziegler Leffingwell Eyecare

    New Berlin, Wisconsin, 53151

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • 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 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.

Conditions
Visual Acuity
Being tested
senofilcon A TEST Lens, senofilcon A CONTROL Lens

What participants receive

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

  • senofilcon A TEST LensDevice

    JJVC Investigational Contact Lens

  • senofilcon A CONTROL LensDevice

    Acuvue Oasys

Study groups in NCT03707821
Study groupRoleWhat they receive
senofilcon A TEST LensExperimentalSubjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the TEST Lens for the duration of the clinical study.
Receives: Device: senofilcon A TEST Lens
senofilcon A CONTROL LensActive comparatorSubjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the CONTROL Lens for the duration of the clinical study.
Receives: Device: senofilcon A CONTROL Lens

What is being measured

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

  1. Overall Comfort Score

    Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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: 2-Week Follow-up Evlauation

  2. Vision Satisfaction in Bright Lighting

    Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ 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 Proportion of responses in each category were reported for each lens type.

    Measured: 2-Week Follow-up Evaluation

  3. Distance Visual Acuity

    Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.

    Measured: 2-Week Follow-up Evlauation

  4. Contact Lens Fitting Acceptance Rate

    Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:

    • limbal exposure at primary gaze or with extreme eye movement;
    • edge lift;
    • excessive movement in primary up gaze;
    • insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

    Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.

    Measured: Up to 2-Week Follow-up

  5. 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). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.

    Measured: Up to 2-Week Follow-up Evlauation

Secondary outcomes (2)

  1. Overall Handling Score

    Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience 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: 2-Week Follow-up Evlauation

  2. Overall Quality of Vision Score

    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 patientexperience 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: 2-Week Follow-up Evlauation

Timeline

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

  1. First posted16 Oct 2018
  2. Study start1 Oct 2018
  3. Primary completion1 Nov 2018
  4. Study completion1 Nov 2018

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
253 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707821
Sponsor's protocol ID
CR-6305
Status last verified
Nov 2019
First submitted
12 Oct 2018
Last updated
5 Dec 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A TEST Lens in people with Visual Acuity, 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 11 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 5 Dec 2019. 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 5 Dec 2019). 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 Score (time frame: 2-Week Follow-up Evlauation). The study lists 5 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 NCT03707821.

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 5 Dec 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT03707821 | AzTrials