Visual AcuityNCT03059810
Clinical Evaluation of Investigational Multifocal Contact Lenses
A study testing etafilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 9 sites in United States.
Trial summary
3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days. 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?
- etafilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Jan 2017to 25 Apr 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".(Appendix B).
- 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 refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
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- The subject's refractive cylinder must be -1.00 D to -1.50 D in each 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 distance 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, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Indiana School of Optometry
Bloomington, Indiana, 47405
Dr. Ted Brink & Associates
Jacksonville, Florida, 32225
Vistakon Research Clinic
Jacksonville, Florida, 32256
Optometry Group, PLLC
Memphis, Tennessee, 38111
Total Eye Care, PA
Memphis, Tennessee, 38119
EYE Center Optometric
Rocklin, California, 95677
Golden Vision
Sarasota, Florida, 34232
Sacco Eye Group
Vestal, New York, 13850
Eye Associates of Winter Park
Winter Park, Florida, 32792
About this study
3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.
- Conditions
- Visual Acuity
- Being tested
- etafilcon A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon ADevice
Investigational Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| Participating Subjects | Experimental | Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits. Receives: Device: etafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall 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: 12-16 Day Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start27 Jan 2017
- Primary completion25 Apr 2017
- Study completion25 Apr 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT03059810
- Sponsor's protocol ID
- CR-5903
- Status last verified
- Dec 2019
- First submitted
- 16 Feb 2017
- Last updated
- 24 Dec 2019
- 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 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Investigational Multifocal Contact Lenses
- ClinicalTrials.gov ID
- NCT03059810
- Acronym / sponsor ID
- CR-5903
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 25 Apr 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 24 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participating Subjects | Experimental | Device: etafilcon AParticipating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits. |
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".(Appendix B).
- 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 (13 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 |
|---|---|---|
| etafilcon AInvestigational Contact Lens | Device | Participating Subjects |
Primary outcome
Overall Vision
Time frame: 12-16 Day 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 9 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 13 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 24 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 9 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 24 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 Vision (time frame: 12-16 Day 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 24 Dec 2019.