The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
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
-
-
Georgia
-
Athens, Georgia, United States, 30602
- The University of Georgia
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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 70 (inclusive) years of age at the time of screening.
- By self-report, habitually wear soft contact lenses (sphere, multifocal, toric) 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 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
- If applicable, those subjects receiving the spherical lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS
- If applicable, those subjects receiving the multifocal lenses will need a vertex-corrected distance refraction within the range of -1.00 through -6.00 DS
- If applicable, those subjects receiving the toric lenses will need a vertex-corrected distance refraction within the range of -1.50 through -4.00 DS, -0.625 through -1.625 DC, and cylinder axes: 80/90/100, 170/180/10
- The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye
Exclusion Criteria:
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 currently using any ocular medications or have any ocular infection of any type.
- By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes 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 habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- Be currently wearing lenses in an extended wear modality.
- Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- 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.
- (Phase 2 only): Have participated in Phase 1 of the study.
- 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 the investigator believes might 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 a history of strabismus or amblyopia.
- 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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Sphere TEST/CONTROL
Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere TEST/CONTROL sequence.
|
Sphere CONTROL
Sphere TEST
|
|
Experimental: Sphere CONTROL/TEST
Eligible subjects who are habitual wearers of soft contact lenses that receive the sphere lenses will be randomized into the sphere CONTROL/TEST sequence.
|
Sphere CONTROL
Sphere TEST
|
|
Experimental: Multifocal TEST/CONTROL
Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal TEST/CONTROL sequence.
|
Multifocal CONTROL
Multifocal TEST
|
|
Experimental: Multifocal CONTROL/TEST
Eligible subjects who are habitual wearers of soft contact lenses that receive the multifocal lenses will be randomized into the multifocal CONTROL/TEST sequence.
|
Multifocal CONTROL
Multifocal TEST
|
|
Experimental: Toric TEST/CONTROL
Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric TEST/CONTROL sequence.
|
Toric CONTROL
Toric TEST
|
|
Experimental: Toric CONTROL/TEST
Eligible subjects who are habitual wearers of soft contact lenses that receive the toric lenses will be randomized into the toric CONTROL/TEST sequence.
|
Toric CONTROL
Toric TEST
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Range at Phase 1
Time Frame: Approximately 15 minutes post lens fitting
|
Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target.
Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.
|
Approximately 15 minutes post lens fitting
|
|
Visual Range at Phase 2
Time Frame: Approximately 15 minutes post lens fitting
|
Visual range is defined as the log relative energy of simulated haze needed to obscure an otherwise high contrast grating target.
Better visual range is indicated by a higher log-relative energy (LRE) of simulated haze (more haze) to obscure an otherwise highly visible target.
|
Approximately 15 minutes post lens fitting
|
|
Motion Detection at Phase 1
Time Frame: Approximately 15 minutes post lens fitting
|
Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position.
Better motion detection is indicated by a smaller distance needed to detect that movement has occurred.
|
Approximately 15 minutes post lens fitting
|
|
Brightness Perception at Phase 1
Time Frame: Approximately 15 minutes post lens fitting
|
Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes.
The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target.
|
Approximately 15 minutes post lens fitting
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motion Detection at Phase 2
Time Frame: Approximately 15 minutes post lens fitting
|
Motion detection is defined as the distance needed (in mm) to determine that a test light has moved from a standard position.
Better motion detection is indicated by a smaller distance needed to detect that movement has occurred.
|
Approximately 15 minutes post lens fitting
|
|
Brightness Perception at Phase 2
Time Frame: Approximately 15 minutes post lens fitting
|
Brightness perception is defined as the log- relative energy needed to match a standard stimulus to a natural scene, across 10 different projected scenes.
The perception of brighter image is indicated by a higher log-relative energy (LRE) needed to match the initially dim standard to the target.
|
Approximately 15 minutes post lens fitting
|
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-6480
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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