Visual AcuityNCT04567186
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population
A study testing Investigational senofilcon A C3 Multifocal Lens and delefilcon A Multifocal Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 sites in United States.
Trial summary
This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Investigational senofilcon A C3 Multifocal Lens and delefilcon A Multifocal Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Sep 2020to 25 Nov 2020
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy all 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.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
- Subjects must own a wearable pair of spectacles if required for their distance vision.
- The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
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- The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or, if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix E).
- The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye.
- The subject's refractive cylinder must be ≤0.75 D in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50 D.
- The subject must have distance best corrected visual acuity of 20/20-3 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.
- Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
- Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
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- Use of any of the following medications within 2 weeks prior to enrollment: oral retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids, oral phenothiazines. See section 9.1 for additional details regarding excluded systemic medications.
- Use of any ocular medication, with the exception of rewetting drops.
- History of herpetic keratitis.
- History of irregular cornea.
- History of pathological dry eye.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
- Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
- Any current ocular infection or inflammation.
- Any current ocular abnormality that may interfere with contact lens wear.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Empire Eye and Laser Center
Bakersfield, California, 93309
Stame & Associates, Eye Care
Jacksonville, Florida, 32256
VRC-East
Jacksonville, Florida, 32256
Spectrum Eyecare
Jamestown, New York, 14701
Eye Associates of New York
Manhattan, New York, 10022
James R. Dugue, OD
Mission Viejo, California, 92691
St. Johns Eye Associates, PA
Saint Augustine, Florida, 32092
About this study
This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.
- Conditions
- Visual Acuity
- Being tested
- Investigational senofilcon A C3 Multifocal Lens, delefilcon A Multifocal Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational senofilcon A C3 Multifocal LensDevice
TEST
delefilcon A Multifocal LensDevice
Also called CONTROL
Dailies Total 1® Multifocal Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| Test/Control/Control | Experimental | Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Test/Control/Control). Receives: Device: Investigational senofilcon A C3 Multifocal Lens; Device: delefilcon A Multifocal Lens |
| Control/Test/Test | Experimental | Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Control/Test/Test). Receives: Device: Investigational senofilcon A C3 Multifocal Lens; Device: delefilcon A Multifocal Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Visual Acuity (logMAR)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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: 1-Week Follow-up
Secondary outcomes (1)
Subjective Overall Vision Scores
Overall vision scores were 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. The average CLUE vision score for each lens type was reported.
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.
- First posted28 Sep 2020
- Study start6 Sep 2020
- Primary completion25 Nov 2020
- Study completion25 Nov 2020
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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567186
- Sponsor's protocol ID
- CR-6392
- Status last verified
- Dec 2021
- First submitted
- 23 Sep 2020
- Last updated
- 21 Jan 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population
- ClinicalTrials.gov ID
- NCT04567186
- Acronym / sponsor ID
- CR-6392
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Sep 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 25 Nov 2020 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Posted 21 Jan 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 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.
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: Investigational senofilcon A C3 Multifocal Lens, Device: delefilcon A Multifocal LensEligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Test/Control/Control). |
| Control/Test/Test | Experimental | Device: Investigational senofilcon A C3 Multifocal Lens, Device: delefilcon A Multifocal LensEligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Control/Test/Test). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Potential subjects must satisfy all the following criteria to be enrolled in the study:
Key exclusion criteria (18 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 |
|---|---|---|
| Investigational senofilcon A C3 Multifocal LensTEST | Device | Control/Test/Test, Test/Control/Control |
| delefilcon A Multifocal LensAlso: CONTROLDailies Total 1® Multifocal Contact Lens | Device | Control/Test/Test, Test/Control/Control |
Primary outcome
Binocular Visual Acuity (logMAR)
Time frame: 1-Week Follow-up
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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.
1 secondary outcome
Subjective Overall Vision Scores
Time frame: 1- Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational senofilcon A C3 Multifocal Lens and delefilcon A Multifocal Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 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 18 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 21 Jan 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?
Binocular Visual Acuity (logMAR) (time frame: 1-Week Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.