Visual AcuityNCT02699593
Clinical Evaluation of Approved Contact Lenses
A study testing Test Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 sites in United States.
Trial summary
This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- Test Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Feb 2016to 1 Apr 2016
- 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 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 at least 18 and not more than 70 years of age (including 70).
- The subject's refractive cylinder must be < 0.75 Diopters (D) in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.
Who cannot join
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
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- Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision or multi-focal contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
- Suspicion of or recent history of alcohol or substance abuse.
- History of serious mental illness.
- History of seizures.
- Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama
Eye Elements Eyecare
Jacksonville, Florida
Advantage Eyecare Associates, LLC
Neodesha, Kansas
Advanced Eyecare, PC
Raytown, Missouri
Timothy R. Poling, OD
Roanoke, Virginia
Golden Vision
Sarasota, Florida
Professional Vision Care
Westerville, Ohio
About this study
This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.
- Conditions
- Visual Acuity
- Being tested
- Test Contact Lens, Control Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test Contact LensDevice
Also called senofilcon A made with material from a new supplier
Control Contact LensDevice
Also called senofilcon A made with material from the current supplier
| Study group | Role | What they receive |
|---|---|---|
| Test / Control Sequence | Experimental | Subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality. Receives: Device: Test Contact Lens; Device: Control Contact Lens |
| Control / Test Sequence | Active comparator | Subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality. Receives: Device: Test Contact Lens; Device: Control Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact Lens Wearing Time
Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.
Measured: 2-week follow-up
Visual Acuity (LogMAR)
Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.
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 posted4 Mar 2016 (estimated)
- Study start1 Feb 2016
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 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
- NCT02699593
- Sponsor's protocol ID
- CR-5809
- Status last verified
- Jun 2017
- First submitted
- 1 Mar 2016
- Last updated
- 12 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Approved Contact Lenses
- ClinicalTrials.gov ID
- NCT02699593
- Acronym / sponsor ID
- CR-5809
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 4 Mar 2016 (estimated)
- Results
- Posted 9 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test / Control Sequence | Experimental | Device: Test Contact Lens, Device: Control Contact LensSubjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality. |
| Control / Test Sequence | Active comparator | Device: Test Contact Lens, Device: Control Contact LensSubjects will be dispensed the Control Contact Lens to wear for two weeks, to be worn in a daily wear modality, attending a follow-up visit in 12-17 days. At the follow-up visit, subjects will be dispensed the Test Contact Lens to wear for two weeks, to be worn in a daily wear modality. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 at least 18 and not more than 70 years of age (including 70).
- The subject's refractive cylinder must be < 0.75 Diopters (D) in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Key exclusion criteria (17 listed)
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
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 |
|---|---|---|
| Test Contact LensAlso: senofilcon A made with material from a new supplier | Device | Control / Test Sequence, Test / Control Sequence |
| Control Contact LensAlso: senofilcon A made with material from the current supplier | Device | Control / Test Sequence, Test / Control Sequence |
Primary outcome
Contact Lens Wearing Time
Time frame: 2-week follow-up
Contact lens wearing time was collected for each subject at the 2-week follow-up evaluation. The average contact lens wearing time in hours was reported for each lens.
Visual Acuity (LogMAR)
Time frame: 2-week Follow-up
Distance Visual Acuity (LogMAR) was assessed using an ETDRS chart at the 2-week follow-up for each subject and eye for 2 conditions, Bright low contrast and Dim high contrast. The average visual acuity (LogMAR) for each condition and lens was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 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 8 inclusion and 17 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 12 Jul 2017. 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. 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 9 Jun 2017). 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?
Contact Lens Wearing Time (time frame: 2-week follow-up). The study lists 2 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 12 Jul 2017.