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

Pete Kollbaum, OD, PhD

Status: Completed

Conditions: Myopia; Asthenopia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03585790

Kollbaum001

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Multifocal Optics first, then Single Vision Optics

Other group

Description:

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

Treatment:

Device: Contact lens with Single Vision Optics

Device: Contact lens with Multifocal Optics

Single Vision Optics first, then Multifocal Optics

Other group

Description:

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

Treatment:

Device: Contact lens with Single Vision Optics

Device: Contact lens with Multifocal Optics