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OpenTrials
Completed

NCT Number: NCT03585790

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contact lens with Multifocal Optics

Device

This contact lens has optics to aid the accommodative and convergence systems

Contact lens with Single Vision Optics

Device

This contact lens has standard single vision optics

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Pete Kollbaum, OD, PhD

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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