Visual AcuityNCT05300763
Clinical Performance of Senofilcon A Investigational Lens
A study testing senofilcon A prototype and Dailies Total 1 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 19 sites in United States.
Trial summary
This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- senofilcon A prototype and Dailies Total 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 19 sitesUnited States
- Study dates
- 21 Mar 2022to 25 May 2022
- 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 39 years
- All sexes
- Healthy volunteers accepted
- 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.
- Be between 18 and 39 (inclusive) years of age at the time of screening.
- By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily wear or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
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- Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
- Possess a wearable pair of spectacles that provide correction for distance vision.
- The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
- The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
- The best corrected, monocular, distance visual acuity must be 20/25or better in each eye.
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study: Exclusion Criteria after Screening
- The subject must not:
- Be currently pregnant or lactating.
- Be currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
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- Be currently wearing monovision or multifocal contact lenses.
- Be currently wearing lenses in an extended wear modality.
- Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. Exclusion Criteria at Baseline Evaluation
- The subject must not:
- Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed).
- Have a history of strabismus or amblyopia.
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Birmingham Vision Care
Bloomfield, Michigan, 48301
ProCare Vision Centers
Granville, Ohio, 43023
Vue Optical Boutique
Jacksonville, Florida, 32205
Dr. James Weber & Associates, PA - City Square Blvd
Jacksonville, Florida, 32218
Stam & Associates Eye Care
Jacksonville, Florida, 32256
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Optometry Group, LLC
Memphis, Tennessee, 38111
Total Eye Care
Memphis, Tennessee, 38119
Flora Chen Poveda, OD, PA - Orange Park
Orange Park, Florida, 32073
Southwest Orlando Eye Care
Orlando, Florida, 32819
Kannarr Eye Care
Pittsburg, Kansas, 66762
VisualEyes
Roswell, Georgia, 30076
Botetourt Eyecare, LLC
Salem, Virginia, 24153
Randall Go, OD
San Francisco, California, 94110
Tallahassee Eye Center
Tallahassee, Florida, 32308
Tyler Eye Associates
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850
Dr. David W. Ferris & Associates
Warwick, Rhode Island, 02888
About this study
This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.
- Conditions
- Visual Acuity
- Being tested
- senofilcon A prototype, Dailies Total 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
senofilcon A prototypeDevice
Test
Dailies Total 1Device
Control
| Study group | Role | What they receive |
|---|---|---|
| TEST LENS | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the TEST Lens for the duration of the study. Receives: Device: senofilcon A prototype |
| CONTROL LENS | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the CONTROL Lens for the duration of the study. Receives: Device: Dailies Total 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of Day Comfort
End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.
Measured: 2-Week Follow-up
Secondary outcomes (3)
Digital Device Use
Lens performance in digital device use was assessed using an individual item "Reduction in the feeling of tired eyes from using a computer or other digital device". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.
Measured: 2-Week Follow-up
Comfort Throughout the Day
Comfort throughout the day was measured using an individual item "I could wear these contact lenses comfortably for as long as I wanted to". Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree.
Measured: 2-Week Follow-up
Comfortable Vision While Night Driving
Comfortable vision while night driving was assessed using an individual item "Ability to see comfortably while driving at night". Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor. "Not Applicable" was excluded from the analysis.
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 posted29 Mar 2022
- Study start21 Mar 2022
- Primary completion25 May 2022
- Study completion25 May 2022
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300763
- Sponsor's protocol ID
- CR-6481
- Status last verified
- Jun 2023
- First submitted
- 18 Mar 2022
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Senofilcon A Investigational Lens
- ClinicalTrials.gov ID
- NCT05300763
- Acronym / sponsor ID
- CR-6481
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST LENS | Experimental | Device: senofilcon A prototypeEligible subjects who are habitual soft contact lens wearers will be randomly assigned the TEST Lens for the duration of the study. |
| CONTROL LENS | Experimental | Device: Dailies Total 1Eligible subjects who are habitual soft contact lens wearers will be randomly assigned the CONTROL Lens for the duration of the study. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- 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.
- Be between 18 and 39 (inclusive) years of age at the time of screening.
- By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily wear or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
Key exclusion criteria (15 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study: Exclusion Criteria after Screening
- Be currently pregnant or lactating.
- Be currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
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 A prototypeTest | Device | TEST LENS |
| Dailies Total 1Control | Device | CONTROL LENS |
Primary outcome
End of Day Comfort
Time frame: 2-Week Follow-up
End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.
3 secondary outcomes
Digital Device Use
Time frame: 2-Week Follow-up
Comfort Throughout the Day
Time frame: 2-Week Follow-up
Comfortable Vision While Night Driving
Time frame: 2-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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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.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing senofilcon A prototype and Dailies Total 1 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 19 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 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 22 Jun 2023). 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?
End of Day Comfort (time frame: 2-Week 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 22 Jun 2023.