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Visual AcuityNCT05099380

Validation of Senofilcon A With New UV / HEV Filter

A study testing senofilcon A C3 and senofilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 17 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, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy 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?
senofilcon A C3 and senofilcon A
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
296 participants
Where
17 sitesUnited States
Study dates
5 Oct 2021to 24 Nov 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 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, multifocal, 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. 10. 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.
  • 11. Have any ocular infection. 12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • 13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Birmingham Vision Care

    Bloomfield Township, Michigan, 48301

  • Primary Eyecare Group

    Brentwood, Tennessee, 37027

  • Dr. Debbie H. Kim, OD

    Closter, New Jersey, 07624

  • James T. Fujimoto, O.D.

    Cupertino, California, 95014

  • Dr. James Weber & Associates, PA

    Jacksonville, Florida, 32205

  • Sabal Eye Care

    Longwood, Florida, 32779

  • Flora Chen Poveda, OD, PA

    Orange Park, Florida, 32073

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • VisualEyes, Inc

    Roswell, Georgia, 30076

  • Botetourt Eyecare, LLC

    Salem, Virginia, 24153

  • William J. Bogus, OD, FAAO

    Salt Lake City, Utah, 84106

  • Randall Go, OD

    San Francisco, California, 94110

  • Tallahassee Eye Center

    Tallahassee, Florida, 32308

  • Tyler Eye Associates

    Tyler, Texas, 75703

  • Sacco Eye Group

    Vestal, New York, 13850

  • West Bay Eye Associates

    Warwick, Rhode Island, 02888

  • Professional Vision Care, Inc.

    Westerville, Ohio, 43081

Other trials in United States

About this study

This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy

Conditions
Visual Acuity
Being tested
senofilcon A C3, senofilcon A

What participants receive

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

  • senofilcon A C3Device

    TEST Lens

  • senofilcon ADevice

    CONTROL Lens

Study groups in NCT05099380
Study groupRoleWhat they receive
TEST lensExperimentalEligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the TEST Lens for the duration of the study.
Receives: Device: senofilcon A C3
CONTROL lensActive comparatorEligible subjects that are habitual wearers of silicone hydrogel spherical contact lenses will be randomized to the CONTROL Lens for the duration of the study.
Receives: Device: senofilcon A

What is being measured

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

  1. Overall Quality of Vision Score

    Overall quality of vision score 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 CLUE vision score for each lens type was reported.

    Measured: 2-Week Follow-up

  2. Distance Monocular logMAR Visual Acuity

    Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meter) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

    Measured: 2-Week Follow-up

  3. Proportion of Eyes With 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, 2-week follow-up and final evaluation). The data was then dichotomized into two groups. Those with Grade 3 or higher SLF and those with Grade 2 or lower. The proportion of eyes with Grade 3 or higher SLF was reported.

    Measured: up to 2-week follow-up

  4. Proportion of Eyes With Unacceptable Lens Fitting

    Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope 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 unacceptable lens fit was reported. Summaries presented in the Participant flow are summarized by planned arm, where as summaries for this measure are summarized by actual arm. One subject was dispensed the incorrect study lens, there for, the number of subjects that were randomized to the Control were 149 but 150 subjects were actually dispensed the control.

    Measured: Up to 2-Week Follow-up

Secondary outcomes (4)

  1. 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

  2. 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

  3. Situational Visual Performance - Indoors

    Indoor performance was assessed using the individual questionnaire item "Clarity of Vision indoors in bright light" with a 5-point Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) and a Not Applicable response option. Subject responses were reported by lens using frequencies.

    Measured: 2-Week Follow-up

  4. Situational Visual Performance - Digital Devices

    Situational visual performance related to digital device use was assessed using the individual preference item "Overall preference while using computer screens \& digital devices". The response set include: Strongly prefer my habitual lenses, Slightly prefer my habitual lenses, No Preference, Slightly prefer the study lenses and Strongly prefer the study lenses. Responses were collapsed into three categories for analysis purpose: Prefer Study Lens, No Preference, Prefer Habitual Lens. Subject responses were reported by lens using frequencies.

    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.

  1. First posted29 Oct 2021
  2. Study start5 Oct 2021
  3. Primary completion24 Nov 2021
  4. Study completion24 Nov 2021

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
296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05099380
Sponsor's protocol ID
CR-6470
Status last verified
Jan 2023
First submitted
4 Oct 2021
Last updated
6 Feb 2023
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

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A C3 and senofilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 17 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 12 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 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 6 Feb 2023). 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). 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 NCT05099380.

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 6 Feb 2023.

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