Visual AcuityNCT02345720
Effects of Multifocal Contact Lens on Ocular Tissue
A study testing etafilcon - PVP (multi-focal) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal) 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 - PVP (multi-focal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2014to May 2015
- 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.
- The subject must be between 40 and 70 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.
- The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
- The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
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- The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- Subjects 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 5 days per week for at least 8 hours per day, for one month or more duration).
- The subject must 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
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
- Any ocular or systemic allergies that contraindicate contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medications, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
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- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- History of herpetic keratitis.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
- History of diabetes.
- Habitual wearer of etafilcon-A contact lens material.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
- Conditions
- Visual Acuity
- Being tested
- etafilcon - PVP (multi-focal)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon - PVP (multi-focal)Device
The investigational contact lens must be worn at least six hours daily.
| Study group | Role | What they receive |
|---|---|---|
| etafilcon - PVP (multi-focal) | Experimental | The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study. Receives: Device: etafilcon - PVP (multi-focal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Eye Lid Margin Staining
Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.
Measured: 30 days Post wear
Limbal Staining
Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
Measured: 30 Days Post Wear
Corneal Staining
The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
Measured: 30 Days Post Wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015
- Study completionMay 2015
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT02345720
- Sponsor's protocol ID
- CR-5632
- Status last verified
- Oct 2016
- First submitted
- 19 Jan 2015
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study
- ClinicalTrials.gov ID
- NCT02345720
- Acronym / sponsor ID
- CR-5632
- 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
- Dec 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 5 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| etafilcon - PVP (multi-focal) | Experimental | Device: etafilcon - PVP (multi-focal)The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study. |
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.
- The subject must be between 40 and 70 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.
- The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
Key exclusion criteria (15 listed)
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
- Any ocular or systemic allergies that contraindicate contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medications, with the exception of rewetting drops.
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 - PVP (multi-focal)The investigational contact lens must be worn at least six hours daily. | Device | etafilcon - PVP (multi-focal) |
Primary outcome
Upper Eye Lid Margin Staining
Time frame: 30 days Post wear
Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.
Limbal Staining
Time frame: 30 Days Post Wear
Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
Corneal Staining
Time frame: 30 Days Post Wear
The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 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 etafilcon - PVP (multi-focal) in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.
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 15 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 Jun 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 Kingdom. 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 5 Oct 2016). 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?
Upper Eye Lid Margin Staining (time frame: 30 days Post wear). The study lists 3 primary outcomes in all. 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 Jun 2018.