Vision CorrectionNCT02036320
A Non-dispensing Fit Evaluation of Investigational Limbal Ring Soft Contact Lenses With Polyvinylpyrrolidone (PVP) in Asian Eyes
A study testing etafilcon A in people with Vision Correction, run by Johnson & Johnson Vision Care, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this clinical trial is to compare the overall lens fit acceptance of two different soft contact lenses in an Asian population. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vision Correction
- 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
- 190 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2014to Feb 2014
- 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 18 to 41 years
- Women only
- Healthy volunteers accepted
- 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 the clinical protocol.
- The subject must be an Asian female (self-reported).
- The subject must be at least 18 years old and less than 41 years old.
- The subject must meet two of the four East Asian anatomical categories (Appendix D) and have a prominent epicanthic fold to be classified East Asian ethnicity. For the purpose of this protocol, East Asian ethnicities may include: China, Japan, Korea, Taiwan, Vietnam, Hong Kong, Malaysia, and Singapore but are not inclusive of these regions.
- The subject must be a habitual soft contact lens wearer. Habitual is defined as: at least one month of daily wear where the lenses are worn a minimum of six (6) hours per day and a minimum of three (3) days per week prior to enrollment in the study.
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- The subject's optimal non-vertexed spherical equivalent distance correction (based on their optimal sphero-cylinder refraction) must be between +2.00 D and -12.00 D.
- Any cylinder power must be less than or equal to -1.00 D confirmed by refraction.
- The subject must possess a functional/usable pair of spectacles and wear them to the visit (only if applicable-to the investigator's discretion).
- The subject's best correctable visual acuity is 20/40 or better (OD and OS) at the baseline visit.
Who cannot join
- Ocular or systemic allergies which might interfere with contact lens wear.
- Ocular or systemic disease which might interfere with contact lens wear.
- Any known hypersensitivity or allergic reaction to contact lenses or contact lens solutions.
- Use of any ocular or topical medication.
- Use of any systemic (oral) medication that is taken for an ocular condition which might interfere with contact lens wear.
- Use of any systemic (oral) medication that is taken for a systemic condition which might interfere with the contact lens wear (this determination will be at the discretion of the investigator).
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- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection or any other abnormalities of the cornea and/or conjunctiva which would contraindicate contact lens wear.
- Rigid gas permeable or hybrid design (rigid gas permeable center and a soft lens skirt) contact lens wear within the past 30 days.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous or planned (during duration of the study), ocular or intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), peripheral iridotomy, etc.)
- Pregnancy or lactation.
- Diabetes.
- Infectious disease.
- Habitual contact lens type is multifocal, monovision or worn as extended wear.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Suspicion of or recent history od alcohol or substance abuse.
- History of serious mental illness.
- History of seizures.
- Employee or family member of the investigational clinic (e.g. Investigator, Coordinator, Technician).
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Study site
Berkeley, California, 94720
Study site
Cleveland, Ohio, 44106
Study site
Dallas, Texas, 75390
Study site
Fullerton, California, 92831
Study site
Houston, Texas, 77204
Study site
New York, New York, 12207
About this study
The purpose of this clinical trial is to compare the overall lens fit acceptance of two different soft contact lenses in an Asian population.
- Conditions
- Vision Correction
- 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
Each study subject will be exposed to both test lenses following a washout period of five minutes between test periods.
| Study group | Role | What they receive |
|---|---|---|
| etafilcon A with additive printed limbal ring | Experimental | Each subject will insert the trial lens while being observed by a technician prior to assessment by the study investigator. Receives: Device: etafilcon A |
| etafilcon A | Active comparator | Each subject will insert the trial lens while being observed by a technician prior to assessment by the study investigator. Receives: Device: etafilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Lens Fit Acceptance
The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.
Measured: 15 mins post insertion
Cosmetic Lens Fit Acceptance
The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.
Measured: 15 mins post insertion
Lens Does Not Exhibit "Hula Hoop" Effect
The number of subjects that did not exhibit a "hula hoop" effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp.
Measured: 15 mins post insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
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 Vision CorrectionStudies 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
- None (open label)
- Enrolment
- 190 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
- NCT02036320
- Sponsor's protocol ID
- CR-5477
- Status last verified
- Sep 2015
- First submitted
- 10 Jan 2014
- 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
- A Non-dispensing Fit Evaluation of Investigational Limbal Ring Soft Contact Lenses With Polyvinylpyrrolidone (PVP) in Asian Eyes
- ClinicalTrials.gov ID
- NCT02036320
- Acronym / sponsor ID
- CR-5477
- Conditions
- Vision Correction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Posted 5 Oct 2015
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 clinical trial is to compare the overall lens fit acceptance of two different soft contact lenses in an Asian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| etafilcon A with additive printed limbal ring | Experimental | Device: etafilcon AEach subject will insert the trial lens while being observed by a technician prior to assessment by the study investigator. |
| etafilcon A | Active comparator | Device: etafilcon AEach subject will insert the trial lens while being observed by a technician prior to assessment by the study investigator. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 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 the clinical protocol.
- The subject must be an Asian female (self-reported).
- The subject must be at least 18 years old and less than 41 years old.
- The subject must meet two of the four East Asian anatomical categories (Appendix D) and have a prominent epicanthic fold to be classified East Asian ethnicity. For the purpose of this protocol, East Asian ethnicities may include: China, Japan, Korea, Taiwan, Vietnam, Hong Kong, Malaysia, and Singapore but are not inclusive of these regions.
Key exclusion criteria (19 listed)
- Ocular or systemic allergies which might interfere with contact lens wear.
- Ocular or systemic disease which might interfere with contact lens wear.
- Any known hypersensitivity or allergic reaction to contact lenses or contact lens solutions.
- Use of any ocular or topical medication.
- Use of any systemic (oral) medication that is taken for an ocular condition which might interfere with 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 AEach study subject will be exposed to both test lenses following a washout period of five minutes between test periods. | Device | etafilcon A, etafilcon A with additive printed limbal ring |
Primary outcome
Mechanical Lens Fit Acceptance
Time frame: 15 mins post insertion
The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.
Cosmetic Lens Fit Acceptance
Time frame: 15 mins post insertion
The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.
Lens Does Not Exhibit "Hula Hoop" Effect
Time frame: 15 mins post insertion
The number of subjects that did not exhibit a "hula hoop" effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp.
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.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing etafilcon A in people with Vision Correction, run by Johnson & Johnson Vision Care, Inc. at 7 sites in 2 countries.
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 10 inclusion and 19 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 7 sites in United States, Canada. 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 2015). 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?
Mechanical Lens Fit Acceptance (time frame: 15 mins post insertion). 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.