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

• Sponsor: Pete Kollbaum, OD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03585790
• Collaborator: Alcon Research (Industry)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 27.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthenopia; Myopia	Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers
• Actual Study Start Date: Sep 13, 2018
• Actual Primary Completion Date: Nov 2, 2018
• Actual Study Completion Date: Nov 2, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Subject Reported Eye Fatigue [1 week]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Clinical Optics Research Lab	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Pete Kollbaum, OD, PhD
• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 8, 2017

More Information

Publications

None provided.

• Responsible Party: Pete Kollbaum, OD, PhD, Principal Investigator, Indiana University
• ClinicalTrials.gov Identifier: NCT03585790
• Other Study ID Numbers: Kollbaum001
• First Posted: Jul 13, 2018
• Last Update Posted: Jan 7, 2020
• Last Verified: Dec 1, 2019

• 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
• Keywords provided by Pete Kollbaum, OD, PhD, Principal Investigator, Indiana University: Eye Fatigue
• Additional relevant MeSH terms: Asthenopia

Study Results

Participant Flow

Arm/Group Title	Multifocal Optics First, Then Single Vision Optics	Single Vision Optics First, Then Multifocal Optics
Arm/Group Description	First intervention (1 week) Second intervention (1 week)	First Intervention (1 week) Second Intervention (1 week)
Period Title: First Intervention (1 Week)
STARTED	23	22
COMPLETED	23	22
NOT COMPLETED	0	0
Period Title: First Intervention (1 Week)
STARTED	23	22
COMPLETED	23	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Multifocal Optics First, Then Single Vision Optics	Single Vision Optics First, Then Multifocal Optics	Total
Arm/Group Description	First Intervention (1 week) Second Intervention (1 week)	First Intervention (1 week) Second Intervention (1 week)	Total of all reporting groups
Overall Participants	23	22	45
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 100%	22 100%	45 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.87 (3.37)	22.5 (3.01)	22.17 (3.25)
Sex: Female, Male (Count of Participants)
Female	19 82.6%	16 72.7%	35 77.8%
Male	4 17.4%	6 27.3%	10 22.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 4.3%	4 18.2%	5 11.1%
Not Hispanic or Latino	22 95.7%	18 81.8%	40 88.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 8.7%	3 13.6%	5 11.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 4.5%	1 2.2%
White	21 91.3%	16 72.7%	37 82.2%
More than one race	0 0%	2 9.1%	2 4.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	23 100%	22 100%	45 100%

Outcome Measures

1. Primary Outcome

Title	Subject Reported Eye Fatigue
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Outcome measures reported for both groups combined secondary to crossover design.

Arm/Group Title	Multifocal Optics First, Then Single Vision Optics	Single Vision Optics First, Then Multifocal Optics	Total
Arm/Group Description	First Intervention (1 week) Second Intervention (1 week)	First Intervention (1 week) Second Intervention (1 week)	Total of all reporting groups
Measure Participants	23	22	45
Single Vision	18	21	21
Multifocal	17	21.5	20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Multifocal Optics First, Then Single Vision Optics
	Comments	Ho: Single Vision - Multifocal >= M vs. Ho: Single Vision - Multifocal < M. Alpha = 0.05, two sided beta = 0.80
	Type of Statistical Test	Non-Inferiority
	Comments	Margin acceptable mean difference (Single Vision - Multifocal) = -5 rating units (0-100 scale, 0 = optimal)
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	through study completion, an average of 1 month
Arm/Group Title	Multifocal Optics First, Then Single Vision Optics		Single Vision Optics First, Then Multifocal Optics
Arm/Group Description	First Intervention (1 week) Second Intervention (1 week)		First Intervention (1 week) Second Intervention (1 week)
All Cause Mortality
	Multifocal Optics First, Then Single Vision Optics		Single Vision Optics First, Then Multifocal Optics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Serious Adverse Events
	Multifocal Optics First, Then Single Vision Optics		Single Vision Optics First, Then Multifocal Optics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Multifocal Optics First, Then Single Vision Optics		Single Vision Optics First, Then Multifocal Optics
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.