Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
Primary Purpose
Visual Acuity
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
senofilcon A
Control
Sponsored by
About this trial
This is an interventional treatment trial for Visual Acuity
Eligibility Criteria
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
- Between 18 and 35 (inclusive) years of age at the time of screening
- The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)
The subject must meet all of the following three criteria:
- The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive)
- The eyes' refractive cylinder must be less than or equal to -0.75 DC
- Each eye must have best corrected visual acuity of 20/25 or better.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type)
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating
- 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, by self-report, which are known to interfere with contact lens wear and/or participation in the study
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear or may impact the functioning of the tear film (e.g., Isotretinoin)
- 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 current use of ocular medication
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron scale
- Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear
- Any known hypersensitivity or allergic reaction to contact lens care products.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
- Employee of clinical site (e.g., Investigator, Coordinator, Technician)
- Current wearers of Acuvue Oasys 1-Day brand contact lenses
Sites / Locations
- VRC East
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TEST/SCR
SCR/TEST
Arm Description
Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially
Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially
Outcomes
Primary Outcome Measures
Visual Acuity (logMAR)
Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.
Secondary Outcome Measures
Area Under Contrast Sensitivity Function Curve
Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.
Full Information
NCT ID
NCT03222037
First Posted
July 17, 2017
Last Updated
August 29, 2019
Sponsor
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03222037
Brief Title
Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
Official Title
Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
August 4, 2017 (Actual)
Study Completion Date
August 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a total of 3 visits where all study endpoints will be measured in all subjects at baseline with habitual lenses and under the two testing treatments sequentially in separate visits based on the randomization scheme
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Acuity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TEST/SCR
Arm Type
Experimental
Arm Description
Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially
Arm Title
SCR/TEST
Arm Type
Experimental
Arm Description
Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially
Intervention Type
Device
Intervention Name(s)
senofilcon A
Intervention Description
Acuvue Oasys 1-Day
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
Trial Frame with best spherocylindrical refraction (SCR)
Primary Outcome Measure Information:
Title
Visual Acuity (logMAR)
Description
Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.
Time Frame
15 Minutes post Treatment Administration
Secondary Outcome Measure Information:
Title
Area Under Contrast Sensitivity Function Curve
Description
Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System. During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet). After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.
Time Frame
15 minutes post treatment administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Between 18 and 35 (inclusive) years of age at the time of screening
The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)
The subject must meet all of the following three criteria:
The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive)
The eyes' refractive cylinder must be less than or equal to -0.75 DC
Each eye must have best corrected visual acuity of 20/25 or better.
The subject must have normal eyes (i.e., no ocular medications or infections of any type)
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
Currently pregnant or lactating
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, by self-report, which are known to interfere with contact lens wear and/or participation in the study
Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear or may impact the functioning of the tear film (e.g., Isotretinoin)
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 current use of ocular medication
Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron scale
Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear
Any known hypersensitivity or allergic reaction to contact lens care products.
Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
Employee of clinical site (e.g., Investigator, Coordinator, Technician)
Current wearers of Acuvue Oasys 1-Day brand contact lenses
Facility Information:
Facility Name
VRC East
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
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