Visual AcuityNCT03755882
Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
A study testing ACUVUE® DEFINE™ Vivid Style and LACELLE™ Sparkling Brown in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in China.
Trial summary
This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks. 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?
- ACUVUE® DEFINE™ Vivid Style and LACELLE™ Sparkling Brown
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2018to 26 Dec 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 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.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol (ie, willing to wear only the study lenses and not use habitual lenses during the study).
- Females between 18 and 29 (inclusive) years of age at the time of screening
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -2.00 D to -7.00 D (inclusive) in each eye.
- The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye.
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- Have spherical best corrected logMAR visual acuity (VA) of 0.18 or better in each eye.
- 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.
- Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers.
- The subject must be willing to be photographed and/or video-taped
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- 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.)
- 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
1 site in 1 country.
About this study
This will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.
- Conditions
- Visual Acuity
- Being tested
- ACUVUE® DEFINE™ Vivid Style, LACELLE™ Sparkling Brown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUVUE® DEFINE™ Vivid StyleDevice
Also called etafilcon A
TEST Lens
LACELLE™ Sparkling BrownDevice
Also called helifilcon A
CONTROL Lens
| Study group | Role | What they receive |
|---|---|---|
| TEST/CONTROL | Experimental | Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences. Receives: Device: ACUVUE® DEFINE™ Vivid Style; Device: LACELLE™ Sparkling Brown |
| CONTROL/TEST | Experimental | Female subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences. Receives: Device: ACUVUE® DEFINE™ Vivid Style; Device: LACELLE™ Sparkling Brown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Performance
Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: Up to 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 posted28 Nov 2018
- Study start5 Nov 2018
- Primary completion26 Dec 2018
- Study completion26 Dec 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 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
- NCT03755882
- Sponsor's protocol ID
- CR-6286
- Status last verified
- Jan 2020
- First submitted
- 26 Nov 2018
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
- ClinicalTrials.gov ID
- NCT03755882
- Acronym / sponsor ID
- CR-6286
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 26 Dec 2018 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 10 Jan 2020
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 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 crossover study. If a subject is found to meet all eligibility criteria, they will be randomized to one of two lens wear sequences. Each lens type will be worn for approximately 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST/CONTROL | Experimental | Device: ACUVUE® DEFINE™ Vivid Style, Device: LACELLE™ Sparkling BrownFemale subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences. |
| CONTROL/TEST | Experimental | Device: ACUVUE® DEFINE™ Vivid Style, Device: LACELLE™ Sparkling BrownFemale subjects between the ages of 18 to 29 years who are habitual reusable soft cosmetic contact lens wearers will be randomized into one of two lens sequences. |
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:
Key exclusion criteria (9 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 |
|---|---|---|
| ACUVUE® DEFINE™ Vivid StyleAlso: etafilcon ATEST Lens | Device | CONTROL/TEST, TEST/CONTROL |
| LACELLE™ Sparkling BrownAlso: helifilcon ACONTROL Lens | Device | CONTROL/TEST, TEST/CONTROL |
Primary outcome
Visual Performance
Time frame: Up to 2-Week Follow-up
Monocular visual performance (logMAR) was evaluated under 3 conditions (1.high luminance and high contrast, 2. High Lumiance Low Contrast and 3. Low Luminance High Contrast with distance goggles) at 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Letter-by-letter results were calculated to ascertain the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACUVUE® DEFINE™ Vivid Style and LACELLE™ Sparkling Brown in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site in China.
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 5 Feb 2020. 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 China. 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 10 Jan 2020). 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?
Visual Performance (time frame: Up to 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 5 Feb 2020.