Visual AcuityNCT04968925
Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
A study testing ACUVUE Oasys 1-Day and Precision 1 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 10 sites in United States.
Trial summary
This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity
- What is being tested?
- ACUVUE Oasys 1-Day and Precision 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Jul 2021to 25 Oct 2021
- 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 40 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:
- 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 40 (inclusive) years of age at the time of screening.
- By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
- By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.
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- The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D) must be between -1.00 and -4.00 DS (inclusive) in each eye.
- The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.
- The subject must have best corrected visual acuity of 20/25 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:
- Be currently pregnant or breastfeeding
- 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.
- Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
- Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
- Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
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- Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
- Have a history of amblyopia or strabismus.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.
- 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 any ocular infection.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
ABQ Eye Care
Albuquerque, New Mexico, 87109
VisionPoint Center
Bloomington, Illinois, 61704
ProCare Vision Center
Granville, Ohio, 43023
Gulf Coast Vision Center, Inc.
Houston, Texas, 77054
Maitland Vision Center
Maitland, Florida, 32751
Optometry Group LLC
Memphis, Tennessee, 38111
James R. Dugue Optometry
Mission Viejo, California, 92691
Flora Chen Poveda, OD, PA
Orange Park, Florida, 32073
Visual Eyes, Inc
Roswell, Georgia, 30076
Tyler Eye Associates
Tyler, Texas, 75703
About this study
This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.
- Conditions
- Visual Acuity
- Being tested
- ACUVUE Oasys 1-Day, Precision 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUVUE Oasys 1-DayDevice
TEST
Precision 1Device
CONTROL
| Study group | Role | What they receive |
|---|---|---|
| O1D/P1 | Experimental | Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1) Receives: Device: ACUVUE Oasys 1-Day; Device: Precision 1 |
| P1/O1D | Experimental | Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D) Receives: Device: ACUVUE Oasys 1-Day; Device: Precision 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Comfort (Phase I)
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
End of Day Comfort (Phase I)
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
End of Day Dryness (Phase I)
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
End of Day Comfort (Phase II)
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
End of Day Dryness (Phase II)
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Overall Comfort (Phase II)
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Secondary outcomes (8)
Comfort Throughout the Day (Phase II)
Comfort Throughout the Day was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes feeling comfortable from morning to night" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Comfort While Using Digital Devices (Phase II)
Comfort while Using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Remaining comfortable while using computer screens and other digital devices (phones, tablets)" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Dryness While Using Digital Devices (Phase II)
Dryness while using Digital Devices was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry while using computer screens and other digital devices (phones, tablets)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Lens Awareness Upon Insertion (Phase II)
Lens Awareness Upon Insertion was assessed using the individual questionnaire item "I lost awareness of these lenses shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
Measured: 1-Minute Post lens fitting
Comfort Upon Insertion (Phase II)
Comfort Upon Insertion was assessed using the individual questionnaire item "These lenses were comfortable shortly after inserting them (within one minute)" with a 5-point Agreement Response Set of 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. Subject responses are reported by lens using frequencies.
Measured: 1-Minute Post lens fitting
Overall Ease of Handling (Phase II)
Overall Ease of Handling was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall ease of handling the lenses (putting them on and taking them off)." with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Ease of Insertion (Phase II)
Ease of Insertion was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Ease of putting the lenses on your eyes " with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Measured: 1-Week Follow-up
Ease of Removal (Phase II)
Ease of Removal was assessed using the individual questionnaire item "how would you rate the study contact lenses on: Ease of taking the lenses off your eyes" with a 6-point Excellence Response Set of 0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
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 posted20 Jul 2021
- Study start12 Jul 2021
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
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
- 302 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
- NCT04968925
- Sponsor's protocol ID
- CR-6456
- Status last verified
- Nov 2022
- First submitted
- 9 Jul 2021
- Last updated
- 22 Dec 2022
- 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 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT04968925
- Acronym / sponsor ID
- CR-6456
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Posted 22 Dec 2022
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 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| O1D/P1 | Experimental | Device: ACUVUE Oasys 1-Day, Device: Precision 1Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1) |
| P1/O1D | Experimental | Device: ACUVUE Oasys 1-Day, Device: Precision 1Eligible subjects that are habitual wearers of daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 40 (inclusive) years of age at the time of screening.
- By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
Key exclusion criteria (11 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or breastfeeding
- 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.
- Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
- Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
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-DayTEST | Device | O1D/P1, P1/O1D |
| Precision 1CONTROL | Device | O1D/P1, P1/O1D |
Primary outcome
Overall Comfort (Phase I)
Time frame: 1-Week Follow-up
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Comfort (Phase I)
Time frame: 1-Week Follow-up
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with aa 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Dryness (Phase I)
Time frame: 1-Week Follow-up
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Comfort (Phase II)
Time frame: 1-Week Follow-up
End of day Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: comfort at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
End of Day Dryness (Phase II)
Time frame: 1-Week Follow-up
End of day Dryness was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Keeping your eyes from feeling dry at the end of the day" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
Overall Comfort (Phase II)
Time frame: 1-Week Follow-up
Overall Comfort was assessed using the individual questionnaire item "How would you rate the study contact lenses on: Overall Comfort" with a 6-point Excellence Response Set of 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor. Subject responses are reported by lens using frequencies.
8 secondary outcomes
Comfort Throughout the Day (Phase II)
Time frame: 1-Week Follow-up
Comfort While Using Digital Devices (Phase II)
Time frame: 1-Week Follow-up
Dryness While Using Digital Devices (Phase II)
Time frame: 1-Week Follow-up
Lens Awareness Upon Insertion (Phase II)
Time frame: 1-Minute Post lens fitting
Comfort Upon Insertion (Phase II)
Time frame: 1-Minute Post lens fitting
Overall Ease of Handling (Phase II)
Time frame: 1-Week Follow-up
Ease of Insertion (Phase II)
Time frame: 1-Week Follow-up
Ease of Removal (Phase II)
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 22 Dec 2022.
- 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 and Precision 1 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 9 inclusion and 11 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 Dec 2022. 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 22 Dec 2022). 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 Comfort (Phase I) (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 22 Dec 2022.