Visual AcuityNCT04529109
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
A study testing etafilcon A investigational cosmetic lens 1 and etafilcon A investigational cosmetic lens 2 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 4 sites in 2 countries.
Trial summary
This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- etafilcon A investigational cosmetic lens 1 and etafilcon A investigational cosmetic lens 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Aug 2020to 15 Sep 2020
- 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 29 years
- Women only
- 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
- Females between 18 and 29 (inclusive) years of age at the time of screening
- Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
- Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report
- Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report.
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- The subject must be willing to be photographed and/or video-taped
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye
- The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye
- Have spherical best corrected visual acuity of 20/25 or better in each eye.
Who cannot join
- Currently pregnant or lactating
- Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion)
- Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
- Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
- Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).
- Participation in any contact lens or lens care product clinical trial within seven (7) days prior to study enrollment
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- Employee or family members of clinical site (eg, 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 (at the investigators discretion)
- Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
Stam & Associates Eye Care
Jacksonville, Florida, 32256
Frazier Vision, Inc
Tyler, Texas, 75703
Hong Kong2 sites
Vital Eyecare Center
Mong Kok, Kowloon
Sight Enhancement Center
Yau Ma Tei, Kowloon
About this study
This will be a randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.
- Conditions
- Visual Acuity
- Being tested
- etafilcon A investigational cosmetic lens 1, etafilcon A investigational cosmetic lens 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etafilcon A investigational cosmetic lens 1Device
TEST
etafilcon A investigational cosmetic lens 2Device
CONTROL
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Test/Control). Receives: Device: etafilcon A investigational cosmetic lens 1; Device: etafilcon A investigational cosmetic lens 2 |
| Control/Test | Experimental | Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Control/Test). Receives: Device: etafilcon A investigational cosmetic lens 1; Device: etafilcon A investigational cosmetic lens 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
Measured: 5- Minutes Post-Lens Fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start13 Aug 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 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
- NCT04529109
- Sponsor's protocol ID
- CR-6395
- Status last verified
- Oct 2021
- First submitted
- 25 Aug 2020
- Last updated
- 24 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
- ClinicalTrials.gov ID
- NCT04529109
- Acronym / sponsor ID
- CR-6395
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Posted 24 Nov 2021
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 randomized, double-masked, bilateral, cross-over, 2 treatment by 2 period dispensing study. There will be 4 visits. There will be a 2 to 5 day washout period between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control | Experimental | Device: etafilcon A investigational cosmetic lens 1, Device: etafilcon A investigational cosmetic lens 2Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Test/Control). |
| Control/Test | Experimental | Device: etafilcon A investigational cosmetic lens 1, Device: etafilcon A investigational cosmetic lens 2Eligible subjects that are habitual soft contact lens wearers and current wearers of circle/cosmetic contact lenses will be randomized into lens wear sequence (Control/Test). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- -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
- Females between 18 and 29 (inclusive) years of age at the time of screening
- Appear able and willing to adhere to the instructions set forth in this clinical protocol (i.e. willing to wear only the study lenses and not use habitual lenses during the dispensing periods)
- Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week over the last month by self-report
Key exclusion criteria (9 listed)
- Currently pregnant or lactating
- Any systemic disease (eg, Sjögren's Syndrome), allergies, infectious disease (eg, hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigators discretion)
- Use of systemic medications (eg, chronic steroid use) that are known to interfere with contact lens wear (at the investigators discretion)
- Any previous or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, LASIK, etc.).
- Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear (at the investigators discretion).
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 A investigational cosmetic lens 1TEST | Device | Control/Test, Test/Control |
| etafilcon A investigational cosmetic lens 2CONTROL | Device | Control/Test, Test/Control |
Primary outcome
Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR
Time frame: 5- Minutes Post-Lens Fitting
Visual acuity on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. However, the data was dichotomized as Y=1 if logMAR visual acuity was less than 0.176 logMAR; and Y=0 otherwise. A value of 0.176 logMAR ≅20/30 Snellen Visual Acuity. The proportion of eyes with visual acuity lower than 0.176 logMAR was reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 investigational cosmetic lens 1 and etafilcon A investigational cosmetic lens 2 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 4 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 9 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 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Hong Kong. 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 24 Nov 2021). 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?
Proportion of Eyes With Distance Monocular Visual Acuity (logMAR) Lower Than 0.176 logMAR (time frame: 5- Minutes Post-Lens Fitting). 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 24 Nov 2021.