Back to resultsAccommodative Relief for Uncomfortable Non-Presbyopes
Primary Purpose
Asthenopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifocal Contact Lens
Single Vision Contact Lens
Sponsored by
About this trial
This is an interventional treatment trial for Asthenopia focused on measuring Contact Lens, Multifocal, Accommodation, Presbyopia
Eligibility Criteria
Inclusion Criteria:
- Visual acuity of 20/25 or better in both eyes with habitual contact lenses
- -0.75 D or more myopic in both eyes
- -0.75 D or less astigmatism in both eyes
- Current single vision contact lens wearer who does not require a reading aid
- CLDEQ-8 score of 12 or more points with habitual contact lenses
- No history of ocular surgery or medication
- Reports digital device use of at least 3 hours per day
- No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
- No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)
Sites / Locations
- The Ohio State University College of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Single Vision First
Multifocal first
Arm Description
Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions.
Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions.
Outcomes
Primary Outcome Measures
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort.
Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT03544216
First Posted
January 12, 2017
Last Updated
January 24, 2019
Sponsor
Ohio State University
Collaborators
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03544216
Brief Title
Accommodative Relief for Uncomfortable Non-Presbyopes
Official Title
Accommodative Relief for Uncomfortable Non-Presbyopes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2017 (Actual)
Primary Completion Date
May 6, 2018 (Actual)
Study Completion Date
May 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Bausch & Lomb Incorporated
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).
Detailed Description
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenopia
Keywords
Contact Lens, Multifocal, Accommodation, Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Vision First
Arm Type
Experimental
Arm Description
Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.Therefore, this group will receive both study interventions.
Arm Title
Multifocal first
Arm Type
Experimental
Arm Description
Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks. Therefore, this group will receive both study interventions.
Intervention Type
Device
Intervention Name(s)
Multifocal Contact Lens
Intervention Description
The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
Intervention Type
Device
Intervention Name(s)
Single Vision Contact Lens
Intervention Description
The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
Primary Outcome Measure Information:
Title
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
Description
After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort.
Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms
Time Frame
Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Visual acuity of 20/25 or better in both eyes with habitual contact lenses
-0.75 D or more myopic in both eyes
-0.75 D or less astigmatism in both eyes
Current single vision contact lens wearer who does not require a reading aid
CLDEQ-8 score of 12 or more points with habitual contact lenses
No history of ocular surgery or medication
Reports digital device use of at least 3 hours per day
No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes)
No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)
Facility Information:
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Accommodative Relief for Uncomfortable Non-Presbyopes
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