The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
NCT ID: NCT03585790
Last Updated: 2020-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2018-09-13
2018-11-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Multifocal Optics first, then Single Vision Optics
First Intervention (1 week) Second Intervention (1 week)
Contact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems
Contact lens with Single Vision Optics
This contact lens has standard single vision optics
Single Vision Optics first, then Multifocal Optics
First Intervention (1 week) Second Intervention (1 week)
Contact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems
Contact lens with Single Vision Optics
This contact lens has standard single vision optics
Interventions
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Contact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems
Contact lens with Single Vision Optics
This contact lens has standard single vision optics
Eligibility Criteria
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Inclusion Criteria
2. Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
3. Mobile digital device with active data and text plan, able to receive email and text messages
4. 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
5. Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
6. 18-35 years of age
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
8. Vertex corrected refractive cylinder must be -0.75 or less.
9. Visual acuity best correctable to 20/25 or better for each eye
10. The subject must read and sign the Informed Consent form.
Exclusion Criteria
2. Any active conditions that may prevent soft contact lens wear.
3. Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
4. Any doctor diagnosed, self-reported accommodative or binocular vision issues
5. History of issues of eye alignment or binocularity by self-report
18 Years
35 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Pete Kollbaum, OD, PhD
OTHER
Responsible Party
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Pete Kollbaum, OD, PhD
Principal Investigator
Locations
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Indiana University Clinical Optics Research Lab
Bloomington, Indiana, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Kollbaum001
Identifier Type: -
Identifier Source: org_study_id
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