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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585790
• Other study ID #: Kollbaum001
• Status: Completed
• Phase: N/A
• Start date: September 13, 2018
• Est. completion date: November 2, 2018

Study information

• Verified date: December 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenopia
• Myopia

Intervention

Device:
• Contact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems
• Contact lens with Single Vision Optics
This contact lens has standard single vision optics

Locations

Country	Name	City	State
United States	Indiana University Clinical Optics Research Lab	Bloomington	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Pete Kollbaum, OD, PhD	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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