Clinical Performance of Three Daily Disposable Silicone Hydrogel Contact Lenses
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Study Contact
- Phone Number: 1-800-843-2020
- Email: jbuch@its.jnj.com
Study Locations
-
-
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Manchester, United Kingdom, M13 9PL
- The University of Manchester, Department of Optometry & Neuroscience
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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, they typically use digital devices for a minimum of 4 hours per day, 5 days per week.
- In a pre-study screening assessment, they must have a CVS-Q score of 6 or greater.
- Agree not to participate in other clinical research while enrolled on this study.
- Own a wearable pair of spectacles, if needed, for distance vision correction (by self-report).
- By self-report, habitually wear silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 8 hours of wear per day, for at least 4 days per week over the past 4 weeks.
- Attain a best-corrected logMAR distance visual acuity of at least 0.20 in each eye.
- Have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on the calculated ocular refraction) in each eye.
- Have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction) in each eye.
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Be currently pregnant or lactating.
- By self-report, have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, which in the opinion of the investigator is likely to interfere with contact lens wear and/or participation in the study or may pose a risk to study personnel.
- Have an ocular disorder which would normally contraindicate contact lens wear.
- 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 or have had worn Acuvue® Oasys 1-Day, Dailies® Total1, or Clariti 1-Day lenses during the last 3 months.
- Have had cataract surgery.
- Have had corneal refractive surgery.
- Be using any topical medications such as eye drops or ointments.
- Have a known hypersensitivity or allergic reaction to sodium fluorescein.
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear. See section 9.1 for additional details regarding excluded systemic medications.
- Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrolment
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- Have clinically significant (grade 3 or higher on the Efron 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 in the opinion of the investigator would 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.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Test Lens 1/Test Lens 2/Test Lens 3
Eligible subjects will be randomized into the Test Lens 1/Test Lens 2/Test Lens 3 sequence, to wear each lens for up to 10 hours each.
|
Acuvue® Oasys MAX 1-Day daily disposable contact lenses
Dailies Total 1 daily disposable contact lenses
Clariti 1-Day daily disposable contact lenses
|
|
Experimental: Test Lens 1/Test Lens 3/Test Lens 2
Eligible subjects will be randomized into the Test Lens 1/Test Lens 3/Test Lens 2 sequence, to wear each lens for up to 10 hours each.
|
Acuvue® Oasys MAX 1-Day daily disposable contact lenses
Dailies Total 1 daily disposable contact lenses
Clariti 1-Day daily disposable contact lenses
|
|
Experimental: Test Lens 2/Test Lens 1/Test Lens 3
Eligible subjects will be randomized into the Test Lens 2/Test Lens 1/Test Lens 3 sequence, to wear each lens for up to 10 hours each.
|
Acuvue® Oasys MAX 1-Day daily disposable contact lenses
Dailies Total 1 daily disposable contact lenses
Clariti 1-Day daily disposable contact lenses
|
|
Experimental: Test Lens 2/Test Lens 3/Test Lens 1
Eligible subjects will be randomized into the Test Lens 2/Test Lens 3/Test Lens 1 sequence, to wear each lens for up to 10 hours each.
|
Acuvue® Oasys MAX 1-Day daily disposable contact lenses
Dailies Total 1 daily disposable contact lenses
Clariti 1-Day daily disposable contact lenses
|
|
Experimental: Test Lens 3/Test Lens 1/Test Lens 2
Eligible subjects will be randomized into the Test Lens 3/Test Lens 1/Test Lens 2 sequence, to wear each lens for up to 10 hours each.
|
Acuvue® Oasys MAX 1-Day daily disposable contact lenses
Dailies Total 1 daily disposable contact lenses
Clariti 1-Day daily disposable contact lenses
|
|
Experimental: Test Lens 3/Test Lens 2/Test Lens 1
Eligible subjects will be randomized into the Test Lens 3/Test Lens 2/Test Lens 1 sequence, to wear each lens for up to 10 hours each.
|
Acuvue® Oasys MAX 1-Day daily disposable contact lenses
Dailies Total 1 daily disposable contact lenses
Clariti 1-Day daily disposable contact lenses
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lens Fit Acceptance
Time Frame: Follow-up assessments will be made approximately 8-10 hours after lens dispensing
|
Lens Fit Acceptance: Lens fit acceptance will be assessed at dispensing and follow-up visits for each subject eye. An unacceptable fit is deemed by one or more of the following criteria:
|
Follow-up assessments will be made approximately 8-10 hours after lens dispensing
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- CR-6595
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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