Visual AcuityNCT03168542
Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2
A study testing JJVC Fitting Guides in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This study is a single arm, non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. 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?
- JJVC Fitting Guides
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 4 May 2017
- 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
- 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.
- Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
- The subject must either 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".
- The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
- The subject's distance spherical equivalent or spherical component (if the eye has - 1.00 to -1.50 D of refractive cylinder) of their refraction must be in the range -1.25 D to -3.75 D or +1.25 D to +3.75 D in each eye.
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- The subject's refractive cylinder cannot be greater than -1.50D in either eye.
- The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- The subject must have a wearable pair of spectacles if required for their distance vision.
Who cannot join
- Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- Pregnancy or lactation.
- Currently diagnosed with diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- 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.
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- 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.
- Any ocular infection or inflammation.
- Any ocular abnormality that may interfere with contact lens wear.
- 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 of clinical site (e.g., Investigator, Coordinator, Technician)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vistakon Research Clinic
Jacksonville, Florida, 32256
About this study
This study is a single arm, non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.
- Conditions
- Visual Acuity
- Being tested
- JJVC Fitting Guides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JJVC Fitting GuidesDevice
Subjects who are habitual soft spherical or toric contact lens wearers, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guide, with either the Multifocal Contact Lens or an Investigational Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes during a 1 day visit.
| Study group | Role | What they receive |
|---|---|---|
| Toric Multifocal Contact Lens | Experimental | JJVC Investigational Toric Multifocal Contact Lens for Presbyopia Receives: Device: JJVC Fitting Guides |
| Multifocal Contact Lens | Experimental | 1-Day Acuvue® Moist Brand Multifocal Contact Lens Receives: Device: JJVC Fitting Guides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fitting Modifications to Optimize Vision
The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.
Measured: 15 Minutes Post Lens Fitting
Secondary outcomes (10)
Subject's Responses to Individual Item 1
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Satisfaction Of These Contact Lenses?". This item had a response set of extremely satisfied, very satisfied, moderately satisfied, slightly satisfied and not at all satisfied. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 2
Subjects responses to individual item "Based On Your Experience Today, How Likely Are You To Purchase This Contact Lens?". This item had a response set of extremely likely, very likely, somewhat likely, slightly likely and not at all likely. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 3
Subjects responses to individual item "Please Think About Your Experience Today With The Study Contact Lenses. Please Indicate How You Satisfied You Are With The Overall Contact Lens Fitting Process?". This item had a response set of very satisfied, satisfied, unsure, dissatisfied and very dissatisfied. The percentage of subject's in each response category was reported
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 4
Subjects responses to individual item "Where Would You Expect To Go Looking For Information About This Contact Lens? Please Select All That Apply.". The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 5
Subjects responses to individual item "If You Were To Purchase The Study Contact Lenses, With What Frequency Would You Expect To Wear Them?". This item had a response set of All of the time, Usually, Frequently, Sometimes, Rarely and never. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 6
Subjects responses to individual item "What Are Your Current Vision Correction Solutions?". The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 7
Subjects responses to individual item "How did the new lens you tried as a part of this clinical study Compare To Your Current Vision Correction Solutions?". This item had a response set of Much better, somewhat better, about the same, somewhat worse and much worse. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 8
Subjects responses to individual item "Considering your experience with the study contact lens, how excited are you about this lens being available to purchase?". This item had a response set of Very Excited, Excited, Unsure, Unexcited and Very Unexcited. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 9
Subjects responses to individual item "How would you rate your overall visual performance with the study contact lens?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 10
Subjects responses to individual item "Considering Your Experience With The Study Contact Lenses, Which Statement Best Describes Your Overall Opinion Of These Contact Lenses?". This item had a response set of Excellent, Very Good, Good, Fair and Poor. The percentage of subject's in each response category was reported.
Measured: 15 Minutes Post Lens Insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 May 2017
- Primary completion4 May 2017
- Study completion4 May 2017
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
- Non-randomised
- Intervention model
- Single group
- Model description
- While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT03168542
- Sponsor's protocol ID
- CR-5955
- Status last verified
- Sep 2018
- First submitted
- 22 May 2017
- Last updated
- 19 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Fitting Investigational Contact Lenses Phase 2
- ClinicalTrials.gov ID
- NCT03168542
- Acronym / sponsor ID
- CR-5955
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a single arm, non-randomized, open label, bilateral, non- dispensing clinical trial with only one visit. The Eye Care Providers will be provided with a fitting guide and will determine the initial study lens selection. Each subject will wear either the investigational contact lenses or marketed contact lenses for approximately 30-90 minutes. This study aims to evaluate the ECPs impression of the fitting guide for a novel multifocal lens and also their success in fitting the lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- While this study utilizes two contact lenses, the purpose was to evaluate the JJVC fitting guide. This was a non-randomized study in which eye care practitioners used the JJVC fitting guide to fit subjects with a study contact lens. Subjects may fit either in a bilateral or a contralateral fashion.
| Arm | Type | Receives |
|---|---|---|
| Toric Multifocal Contact Lens | Experimental | Device: JJVC Fitting GuidesJJVC Investigational Toric Multifocal Contact Lens for Presbyopia |
| Multifocal Contact Lens | Experimental | Device: JJVC Fitting Guides1-Day Acuvue® Moist Brand Multifocal Contact Lens |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
- The subject must either 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".
- The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
Key exclusion criteria (14 listed)
- Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
- Pregnancy or lactation.
- Currently diagnosed with diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
- 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.
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 |
|---|---|---|
| JJVC Fitting GuidesSubjects who are habitual soft spherical or toric contact lens wearers, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guide, with either the Multifocal Contact Lens or an Investigational Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes during a 1 day visit. | Device | Multifocal Contact Lens, Toric Multifocal Contact Lens |
Primary outcome
Number of Fitting Modifications to Optimize Vision
Time frame: 15 Minutes Post Lens Fitting
The ECP followed the fitting guide to assess the vision provided by the study lenses and determined if a lens change was needed. The ECP modified the lenses based upon the subject's responses in accordance with the Fitting Guide. Two modifications were allowed. The number of modifications required by the ECP to optimize vision was recorded.
10 secondary outcomes
Subject's Responses to Individual Item 1
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 2
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 3
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 4
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 5
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 6
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 7
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 8
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 9
Time frame: 15 Minutes Post Lens Insertion
Subject's Responses to Individual Item 10
Time frame: 15 Minutes Post Lens Insertion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JJVC Fitting Guides in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 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 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 19 Oct 2018). 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?
Number of Fitting Modifications to Optimize Vision (time frame: 15 Minutes Post Lens Fitting). 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 19 Oct 2018.