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Clinical Trials/NCT03585790
NCT03585790
Completed
Not Applicable

The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers

Pete Kollbaum, OD, PhD1 site in 1 country45 target enrollmentSeptember 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthenopia
Sponsor
Pete Kollbaum, OD, PhD
Enrollment
45
Locations
1
Primary Endpoint
Subject Reported Eye Fatigue
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 13, 2018
End Date
November 2, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pete Kollbaum, OD, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Pete Kollbaum, OD, PhD

Principal Investigator

Indiana University

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

Outcomes

Primary Outcomes

Subject Reported Eye Fatigue

Time Frame: 1 week

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.

Study Sites (1)

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