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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03585790
Recruitment Status : Completed
First Posted : July 13, 2018
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Pete Kollbaum, OD, PhD, Indiana University

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.

Condition or disease Intervention/treatment Phase
Asthenopia Myopia Device: Contact lens with Multifocal Optics Device: Contact lens with Single Vision Optics Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Actual Study Start Date : September 13, 2018
Actual Primary Completion Date : November 2, 2018
Actual Study Completion Date : November 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Fatigue

Arm Intervention/treatment
Experimental: Arm A Device: Contact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems

Device: Contact lens with Single Vision Optics
This contact lens has standard single vision optics

Placebo Comparator: Arm B Device: Contact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems

Device: Contact lens with Single Vision Optics
This contact lens has standard single vision optics




Primary Outcome Measures :
  1. Subject Reported Eye Fatigue [ Time Frame: 1 week ]
    Rating of Eye Fatigue



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
  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:

  1. A habitual wearer of any of the test lenses
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585790


Locations
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United States, Indiana
Indiana University Clinical Optics Research Lab
Bloomington, Indiana, United States, 47405
Sponsors and Collaborators
Pete Kollbaum, OD, PhD
Alcon Research

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Responsible Party: Pete Kollbaum, OD, PhD, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03585790     History of Changes
Other Study ID Numbers: Kollbaum001
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Pete Kollbaum, OD, PhD, Indiana University:
Eye Fatigue

Additional relevant MeSH terms:
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Asthenopia
Eye Diseases