Visual AcuityNCT03787472
Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population
A study testing JJV Investigational senofilcon A Multifocal Lens1 and JJV Investigational senofilcon A Multifocal Lens2 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 5 sites in United States.
Trial summary
The clinical study is a randomized-controlled, double-masked, crossover clinical trial with two study treatments to compare two study lens types and the initial performance, in terms of the subjective response after a period of lens dispensing. The study will last approximately 2 to 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?
- JJV Investigational senofilcon A Multifocal Lens1 and JJV Investigational senofilcon A Multifocal Lens2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Jan 2019to 22 Mar 2019
- 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.
- 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.
Show all 11Show fewer
- 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.
- 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 8 hours per wear day, for 1 month of more duration).
- 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".
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, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
- Clinically significant (Grade 3 or 4) 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.
Show all 16Show fewer
- Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy cataract surgery, retinal surgery, etc.).
- A history of amblyopia, strabismus or binocular vision abnormality.
- Any current ocular infection or inflammation.
- Any current ocular abnormality that may interfere with contact lens wear.
- Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, systemic steroids.
- Use of any ocular medication, with the exception of rewetting drops.
- History of herpetic keratitis.
- 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 Optifree®Replenish® multipurpose care solution, sodium fluorescein or Eye-Cept® rewetting drop solution.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Western Reserve Vision Care, Inc
Beachwood, Ohio, 44122
ProCare Vision Centers
Granville, Ohio, 43023
Spectrum Eyecare
Jamestown, New York, 14701
Maitland Vision Center
Maitland, Florida, 32751
Advanced Eyecare
Raytown, Missouri, 64133
About this study
Official title: Clinical Evaluation of Manufacturing Curing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population
The clinical study is a randomized-controlled, double-masked, crossover clinical trial with two study treatments to compare two study lens types and the initial performance, in terms of the subjective response after a period of lens dispensing. The study will last approximately 2 to 4 months.
- Conditions
- Visual Acuity
- Being tested
- JJV Investigational senofilcon A Multifocal Lens1, JJV Investigational senofilcon A Multifocal Lens2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JJV Investigational senofilcon A Multifocal Lens1Device
CONTROL
JJV Investigational senofilcon A Multifocal Lens2Device
TEST
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control). Receives: Device: JJV Investigational senofilcon A Multifocal Lens1; Device: JJV Investigational senofilcon A Multifocal Lens2 |
| Control/Test | Experimental | Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/Test). Receives: Device: JJV Investigational senofilcon A Multifocal Lens1; Device: JJV Investigational senofilcon A Multifocal Lens2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CLUE Vision
Overall 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.
Measured: 2-Week Follow-up
Secondary outcomes (1)
logMAR Visual Acuity
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances:
Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start11 Jan 2019
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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
- NCT03787472
- Sponsor's protocol ID
- CR-6317
- Status last verified
- Jun 2020
- First submitted
- 21 Dec 2018
- Last updated
- 23 Jun 2020
- 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 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Manufacturing Curing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population
- ClinicalTrials.gov ID
- NCT03787472
- Acronym / sponsor ID
- CR-6317
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Posted 23 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical study is a randomized-controlled, double-masked, crossover clinical trial with two study treatments to compare two study lens types and the initial performance, in terms of the subjective response after a period of lens dispensing. The study will last approximately 2 to 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control | Experimental | Device: JJV Investigational senofilcon A Multifocal Lens1, Device: JJV Investigational senofilcon A Multifocal Lens2Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into one the sequence (Test/Control). |
| Control/Test | Experimental | Device: JJV Investigational senofilcon A Multifocal Lens1, Device: JJV Investigational senofilcon A Multifocal Lens2Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized into the sequence (Control/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 (16 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 |
|---|---|---|
| JJV Investigational senofilcon A Multifocal Lens1CONTROL | Device | Control/Test, Test/Control |
| JJV Investigational senofilcon A Multifocal Lens2TEST | Device | Control/Test, Test/Control |
Primary outcome
CLUE Vision
Time frame: 2-Week Follow-up
Overall 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.
1 secondary outcome
logMAR Visual Acuity
Time frame: 2-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- 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
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
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
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 JJV Investigational senofilcon A Multifocal Lens1 and JJV Investigational senofilcon A Multifocal Lens2 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 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 23 Jun 2020. 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 23 Jun 2020). 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?
CLUE Vision (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?
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 23 Jun 2020.