Trial Outcomes & Findings for The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers (NCT NCT03585790)

Last Updated: 2020-01-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

1 week

Results posted on

2020-01-07

Participant Flow

Participant milestones

Participant milestones
Measure	Multifocal Optics First, Then Single Vision Optics First intervention (1 week) Second intervention (1 week)	Single Vision Optics First, Then Multifocal Optics First Intervention (1 week) Second Intervention (1 week)
First Intervention (1 Week) STARTED	23	22
First Intervention (1 Week) COMPLETED	23	22
First Intervention (1 Week) NOT COMPLETED	0	0
Second Intervention (1 Week) STARTED	23	22
Second Intervention (1 Week) COMPLETED	23	22
Second Intervention (1 Week) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multifocal Optics First, Then Single Vision Optics n=23 Participants First Intervention (1 week) Second Intervention (1 week)	Single Vision Optics First, Then Multifocal Optics n=22 Participants First Intervention (1 week) Second Intervention (1 week)	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	21.87 years STANDARD_DEVIATION 3.37 • n=5 Participants	22.5 years STANDARD_DEVIATION 3.01 • n=7 Participants	22.17 years STANDARD_DEVIATION 3.25 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	18 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	22 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Multifocal Optics First, Then Single Vision Optics n=23 Participants First Intervention (1 week) Second Intervention (1 week)	Single Vision Optics First, Then Multifocal Optics n=22 Participants First Intervention (1 week) Second Intervention (1 week)	Total n=45 Participants Total of all reporting groups
Subject Reported Eye Fatigue Single Vision	18 units on a scale Interval 6.5 to 39.0	21 units on a scale Interval 15.25 to 48.0	21 units on a scale Interval 11.0 to 45.0
Subject Reported Eye Fatigue Multifocal	17 units on a scale Interval 6.5 to 33.5	21.5 units on a scale Interval 16.75 to 38.75	20 units on a scale Interval 8.0 to 38.0

Adverse Events

Multifocal Optics First, Then Single Vision Optics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Vision Optics First, Then Multifocal Optics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pete Kollbaum

IU School of Optometry

Phone: 812-856-0108

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60