Visual AcuityNCT04849780

Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

A study testing ACUVUE Oasys 1-Day and Habitual Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: ACUVUE Oasys 1-Day and Habitual Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 9 sitesUnited States
Study dates: 17 Apr 2021to 12 Aug 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 59 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.
Between 18 and 59 (inclusive) years of age at the time of screening.
Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report.
Have a CLDEQ-8 score of 15 or greater with the habitual lens.

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Subjects must possess a pair of spectacles for distance correction.
Subject's habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision® MyDay®, or Johnson \& Johnson 1-Day ACUVUE® Moist.
The subject's vertex corrected spherical distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye.
11. Have spherical 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:
Subject's habitual lens is ACUVUE OASYS®1-Day.
Currently pregnant or lactating, by self-report.
Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.

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Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal.
. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (Rx or over the counter (OTC)) that may interfere with contact lens wear (at the discretion of the investigator).
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.
Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Procare Vision Centers
Granville, Ohio, 43023
Vue Optical Boutique
Jacksonville, Florida, 32205
Sabal Eye Care
Longwood, Florida, 32792
Maitland Vision Center
Maitland, Florida, 32751
Optometry Group Pllc
Memphis, Tennessee, 38111
Kannarr Eye Care
Pittsburg, Kansas, 66762
Tyler Eye Associates
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850
Dr. David Ferris & Associates
Warwick, Rhode Island, 02888

Other trials in United States

About this study

This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.

Conditions: Visual Acuity
Being tested: ACUVUE Oasys 1-Day, Habitual Lens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACUVUE Oasys 1-DayDevice
TEST
Habitual LensDevice
Also called CONTROL
Subjects' own Habitual Lenses

Study groups in NCT04849780
Study group	Role	What they receive
ARM 1	Experimental	Eligible subjects will be randomized to the TEST lens to wear in both eyes for approximately 2 weeks. Receives: Device: ACUVUE Oasys 1-Day
ARM 2	Experimental	Eligible subjects will be randomized to the CONTROL lens to wear in both eyes for approximately 2 weeks. Then the subject will receive the TEST lens to wear in both eyes for approximately 2 weeks. Receives: Device: ACUVUE Oasys 1-Day; Device: Habitual Lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline Comfort Score
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 change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.
Measured: Up to 2-Week Follow-up

Secondary outcomes (3)

Change From Baseline CLDEQ-8 Score
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported.
Measured: Up to 2-Week Follow-up
Comfort Score
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 comfort score was reported for each group within Arm 2 only.
Measured: 2-Week Follow-up
CLDEQ-8 Score
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported.
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.

17 Apr 202112 Aug 2021

First posted19 Apr 2021
Study start17 Apr 2021
Primary completion12 Aug 2021
Study completion12 Aug 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04849780
Sponsor's protocol ID: CR-6388
Status last verified: Sep 2022
First submitted: 16 Apr 2021
Last updated: 10 Oct 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
ClinicalTrials.gov ID: NCT04849780
Acronym / sponsor ID: CR-6388
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 17 Apr 2021 (actual)
Primary completion: 12 Aug 2021 (actual)
Study completion: 12 Aug 2021 (actual)
First posted: 19 Apr 2021 (actual)
Results: Posted 10 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ARM 1	Experimental	Device: ACUVUE Oasys 1-DayEligible subjects will be randomized to the TEST lens to wear in both eyes for approximately 2 weeks.
ARM 2	Experimental	Device: ACUVUE Oasys 1-Day, Device: Habitual LensEligible subjects will be randomized to the CONTROL lens to wear in both eyes for approximately 2 weeks. Then the subject will receive the TEST lens to wear in both eyes for approximately 2 weeks.

Who may qualify

Ages: 18 to 59 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:
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.
Between 18 and 59 (inclusive) years of age at the time of screening.
Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report.

Key exclusion criteria (15 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Subject's habitual lens is ACUVUE OASYS®1-Day.
Currently pregnant or lactating, by self-report.
Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).

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	ARM 1, ARM 2
Habitual LensAlso: CONTROLSubjects' own Habitual Lenses	Device	ARM 2

Primary outcome

Change From Baseline Comfort Score
Time frame: Up to 2-Week Follow-up
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 change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance.

3 secondary outcomes

Change From Baseline CLDEQ-8 Score
Time frame: Up to 2-Week Follow-up
Comfort Score
Time frame: 2-Week Follow-up
CLDEQ-8 Score
Time frame: 2-Week Follow-up

Results and safety

Results posted to the registry on 10 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 2	45	41
Arm 1	47	47

Primary outcome: Change From Baseline Comfort Score

Time frame: Up to 2-Week Follow-up. Mean (Standard Deviation). Unit: Units on a scale

Measure	Arm 1 n = 46	Arm 2 (Subjects' Own Contact Lens) n = 39
Value	28.99 (26.766)	-0.29 (10.245)

Arm 1 vs Arm 2 (Subjects' Own Contact Lens): Population Mean Difference: 29.279 (95% CI 24.602 to 33.732), Bootstrapping methods

Population analysed: Subjects that completed all required study visits without a major protocol deviation impacting a primary or secondary endpoint.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the entire duration of the study. For subject in Arm 1 their study duration was approximately 2-weeks while subjects in Arm 2 study duration was approximately 1-month.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 88 (0%)	0 of 88 (0%)	0 of 88
Nelfilcon A	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Delfilcon A	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Somofilcon A	0 of 5 (0%)	0 of 5 (0%)	0 of 5
Stenofilcon A	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Etafilcon A	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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

Related trials for Visual Acuity

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Recruiting
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
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Evaluation of Approved Contact Lenses (CR-6657)
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RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
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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.

9 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 Habitual Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 9 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 10 Oct 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?

Change From Baseline Comfort Score (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?

On the ClinicalTrials.gov record for NCT04849780.

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 10 Oct 2022.