Visual AcuityNCT03597178
Contact Lens Insertion and Removal in a Senior Subject Demographic
A study testing senofilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in United States.
Trial summary
This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2018to 12 Jul 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Must be at least 60 years of age at the time of screening.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type).
- The subject must have best corrected visual acuity (BCVA) of 20/30 or better in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- A habitual and adapted wearer of contact lenses (have worn a contact lens at least one time in the past 5 years).
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Show all 16Show fewer
- 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)
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.
- Conditions
- Visual Acuity
- Being tested
- senofilcon A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon ADevice
ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology
| Study group | Role | What they receive |
|---|---|---|
| senofilcon A | Experimental | Subjects that are of at least 60 years of age and non-habitual contact lens wearers will receive instructions to insert and remove a contact lens from each eye. Receives: Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success Rate of Insertion and Removal of a Contact Lens
The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.
Measured: Lens insertion and Removal, up to 2-Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start29 Jun 2018
- Primary completion12 Jul 2018
- Study completion12 Jul 2018
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Pall, OD, MS, FAAO, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597178
- Sponsor's protocol ID
- CR-6289
- Status last verified
- Aug 2019
- First submitted
- 13 Jul 2018
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contact Lens Insertion and Removal in a Senior Subject Demographic
- ClinicalTrials.gov ID
- NCT03597178
- Acronym / sponsor ID
- CR-6289
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| senofilcon A | Experimental | Device: senofilcon ASubjects that are of at least 60 years of age and non-habitual contact lens wearers will receive instructions to insert and remove a contact lens from each eye. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Key exclusion criteria (16 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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 |
|---|---|---|
| senofilcon AACUVUE OASYS® 1-DAY with HydraLuxe™ Technology | Device | senofilcon A |
Primary outcome
Overall Success Rate of Insertion and Removal of a Contact Lens
Time frame: Lens insertion and Removal, up to 2-Hours
The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Visual Acuity
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
Visual Acuity
Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
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.
Brian Pall, OD, MS, FAAO study director
Johnson & Johnson Vision Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A 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 6 inclusion and 16 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 28 Aug 2019. 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 12 Aug 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 Success Rate of Insertion and Removal of a Contact Lens (time frame: Lens insertion and Removal, up to 2-Hours). 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 28 Aug 2019.