N/A
N=45
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
Asthenopia · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03585790 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Subject Reported Eye Fatigue — 18; 21; 21; 17 units on a scale — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contact lens with Multifocal Optics (Device); Contact lens with Single Vision Optics (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pete Kollbaum, OD, PhD
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Eye Fatigue |
18; 21; 21; 17; 21.5; 20 | 0.18 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03585790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.