Back to resultsThe Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Primary Purpose
Asthenopia, Myopia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contact lens with Multifocal Optics
Contact lens with Single Vision Optics
Sponsored by
About this trial
This is an interventional treatment trial for Asthenopia focused on measuring Eye Fatigue
Eligibility Criteria
Inclusion Criteria:
- Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
- Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
- Mobile digital device with active data and text plan, able to receive email and text messages
- Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
- Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
- 18-35 years of age
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Vertex corrected refractive cylinder must be -0.75 or less.
- Visual acuity best correctable to 20/25 or better for each eye
- The subject must read and sign the Informed Consent form.
Exclusion Criteria:
- A habitual wearer of any of the test lenses
- Any active conditions that may prevent soft contact lens wear.
- Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
- Any doctor diagnosed, self-reported accommodative or binocular vision issues
- History of issues of eye alignment or binocularity by self-report
Sites / Locations
- Indiana University Clinical Optics Research Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Multifocal Optics first, then Single Vision Optics
Single Vision Optics first, then Multifocal Optics
Arm Description
First Intervention (1 week) Second Intervention (1 week)
First Intervention (1 week) Second Intervention (1 week)
Outcomes
Primary Outcome Measures
Subject Reported Eye Fatigue
Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above.
Secondary Outcome Measures
Full Information
NCT ID
NCT03585790
First Posted
April 26, 2018
Last Updated
December 19, 2019
Sponsor
Pete Kollbaum, OD, PhD
Collaborators
Alcon Research
1. Study Identification
Unique Protocol Identification Number
NCT03585790
Brief Title
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Official Title
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 13, 2018 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pete Kollbaum, OD, PhD
Collaborators
Alcon Research
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
5. Study Description
Brief Summary
Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenopia, Myopia
Keywords
Eye Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multifocal Optics first, then Single Vision Optics
Arm Type
Other
Arm Description
First Intervention (1 week) Second Intervention (1 week)
Arm Title
Single Vision Optics first, then Multifocal Optics
Arm Type
Other
Arm Description
First Intervention (1 week) Second Intervention (1 week)
Intervention Type
Device
Intervention Name(s)
Contact lens with Multifocal Optics
Intervention Description
This contact lens has optics to aid the accommodative and convergence systems
Intervention Type
Device
Intervention Name(s)
Contact lens with Single Vision Optics
Intervention Description
This contact lens has standard single vision optics
Primary Outcome Measure Information:
Title
Subject Reported Eye Fatigue
Description
Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above.
Time Frame
1 week
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:
Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
Mobile digital device with active data and text plan, able to receive email and text messages
Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
18-35 years of age
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Vertex corrected refractive cylinder must be -0.75 or less.
Visual acuity best correctable to 20/25 or better for each eye
The subject must read and sign the Informed Consent form.
Exclusion Criteria:
A habitual wearer of any of the test lenses
Any active conditions that may prevent soft contact lens wear.
Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
Any doctor diagnosed, self-reported accommodative or binocular vision issues
History of issues of eye alignment or binocularity by self-report
Facility Information:
Facility Name
Indiana University Clinical Optics Research Lab
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
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