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

NCT03585790 | Completed Results FDA Device

• 1 other identifier: Kollbaum001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthenopia; Myopia

Keywords

Eye Fatigue

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Multifocal Optics first, then Single Vision Optics

OTHER

First Intervention (1 week) Second Intervention (1 week)

Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics

Single Vision Optics first, then Multifocal Optics

OTHER

First Intervention (1 week) Second Intervention (1 week)

Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics

Interventions

Contact lens with Multifocal Optics DEVICE

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

Multifocal Optics first, then Single Vision Optics; Single Vision Optics first, then Multifocal Optics

Contact lens with Single Vision Optics DEVICE

This contact lens has standard single vision optics

Multifocal Optics first, then Single Vision Optics; Single Vision Optics first, then Multifocal Optics

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pete Kollbaum, OD, PhD: lead
• Alcon Research: collaborator

Study Sites (1)

Indiana University Clinical Optics Research Lab

Bloomington, Indiana, 47405, United States

Location

MeSH Terms

Conditions

Asthenopia; Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Pete Kollbaum
• Organization: IU School of Optometry

kollbaum@iu.edu

812-856-0108

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: July 13, 2018
• Study Start: September 13, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: January 7, 2020
• Results First Posted: January 7, 2020

Record last verified: 2019-12

Locations

US (1)