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.

Study Overview

• Status: Completed
• Conditions: Myopia; Asthenopia
• Intervention / Treatment: Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University Clinical Optics Research Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Multifocal Optics first, then Single Vision Optics; First Intervention (1 week) Second Intervention (1 week)	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
Other: Single Vision Optics first, then Multifocal Optics; First Intervention (1 week) Second Intervention (1 week)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 week

Collaborators and Investigators

• Sponsor: Pete Kollbaum, OD, PhD
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2018
• Primary Completion (Actual): November 2, 2018
• Study Completion (Actual): November 2, 2018

Study Registration Dates

• First Submitted: April 26, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 13, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Eye Fatigue
• Additional Relevant MeSH Terms: Eye Diseases; Asthenopia
• Other Study ID Numbers: Kollbaum001

Drug and device information, study documents

• 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