Visual AcuityNCT05778786
Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore
A study testing Acuvue Oasys 1 Day for Astigmatism and TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 10 sites in United States.
Trial summary
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study. 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?
- Acuvue Oasys 1 Day for Astigmatism and TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Mar 2023to 24 May 2023
- 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 years of age (inclusive) at the time of screening.
- Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
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- Possess a wearable pair of spectacles that provide correction for distance vision.
- In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
- Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
- Cylinder powers (DC) -0.75 and -1.25
- Axes (°) 170, 180, 10, 80, 90, 100
- Have best corrected monocular distance visual acuity 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:
- The subject must not:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have an ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that 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.
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- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- Be currently wearing monovision or multifocal contact lenses.
- Be currently wearing lenses in an extended wear modality.
- Have a history of strabismus or amblyopia.
- 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.
- Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- 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 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).
- 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
ProCare Vision Centers
Granville, Ohio, 43023
Stam & Associates Eye Care
Jacksonville, Florida, 32256
Omega Vision Center
Longwood, Florida, 32779
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, LLC
Memphis, Tennessee, 38111
Botetourt Eyecare, LLC
Salem, Virginia, 24153
Tyler Eye Associates
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850
Professional Vision Care Inc. - Westerville
Westerville, Ohio, 43081
About this study
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.
- Conditions
- Visual Acuity
- Being tested
- Acuvue Oasys 1 Day for Astigmatism, TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue Oasys 1 Day for AstigmatismDevice
CONTROL
TRA100/TRA200 series toric contact lens with HEVL-blocking chromophoreDevice
TEST
| Study group | Role | What they receive |
|---|---|---|
| Test/Control | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (test then control) with a washout period of 7+/-2 days duration between wear periods. Receives: Device: Acuvue Oasys 1 Day for Astigmatism; Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore |
| Control/Test | Experimental | Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (control then test) with a washout period of 7+/-2 days duration between wear periods. Receives: Device: Acuvue Oasys 1 Day for Astigmatism; Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Monocular logMAR Visual Acuity
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed 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. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: 1-Week Follow-up
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Measured: 1-Week Follow-up
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Measured: 15-minutes after lens insertion
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
Measured: 15-minutes after lens insertion
Proportion of Eyes With Acceptable Lens Fitting
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.
Measured: Up to 1-Week Follow-up
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
Measured: Up to 1-Week Follow-up
Secondary outcomes (2)
CLUE Comfort Score
Subjective comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE comfort score was reported.
Measured: 1-Week Follow-up
CLUE Handling Score
Subjective handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE handling score was reported.
Measured: 1-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 posted21 Mar 2023
- Study start13 Mar 2023
- Primary completion24 May 2023
- Study completion24 May 2023
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
- 188 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
- NCT05778786
- Sponsor's protocol ID
- CR-6521
- Status last verified
- Jun 2024
- First submitted
- 10 Mar 2023
- Last updated
- 17 Jul 2024
- 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 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore
- ClinicalTrials.gov ID
- NCT05778786
- Acronym / sponsor ID
- CR-6521
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Posted 17 Jul 2024
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, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.
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 Oasys 1 Day for Astigmatism, Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophoreEligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (test then control) with a washout period of 7+/-2 days duration between wear periods. |
| Control/Test | Experimental | Device: Acuvue Oasys 1 Day for Astigmatism, Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophoreEligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (control then test) with a washout period of 7+/-2 days duration between wear periods. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 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 years of age (inclusive) at the time of screening.
- Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
Key exclusion criteria (15 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- Be diabetic.
- Be currently using any ocular medications or have an ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that 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.
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 Oasys 1 Day for AstigmatismCONTROL | Device | Control/Test, Test/Control |
| TRA100/TRA200 series toric contact lens with HEVL-blocking chromophoreTEST | Device | Control/Test, Test/Control |
Primary outcome
Distance Monocular logMAR Visual Acuity
Time frame: 1-Week Follow-up
Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed 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. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
CLUE Vision Score
Time frame: 1-Week Follow-up
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees
Time frame: 15-minutes after lens insertion
Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.
Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees
Time frame: 15-minutes after lens insertion
Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.
Proportion of Eyes With Acceptable Lens Fitting
Time frame: Up to 1-Week Follow-up
Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
Time frame: Up to 1-Week Follow-up
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.
2 secondary outcomes
CLUE Comfort Score
Time frame: 1-Week Follow-up
CLUE Handling Score
Time frame: 1-Week Follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- 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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuvue Oasys 1 Day for Astigmatism and TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 10 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 12 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 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 17 Jul 2024). 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?
Distance Monocular logMAR Visual Acuity (time frame: 1-Week Follow-up). The study lists 6 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 17 Jul 2024.