Asthenopia, Myopia
Conditions
Keywords
Eye Fatigue
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.
Interventions
DEVICEContact lens with Multifocal Optics
This contact lens has optics to aid the accommodative and convergence systems
DEVICEContact lens with Single Vision Optics
This contact lens has standard single vision optics
Sponsors
Alcon Research
Pete Kollbaum, OD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Multifocal Optics First, Then Single Vision Optics First Intervention (1 week) Second Intervention (1 week) | 23 |
| Single Vision Optics First, Then Multifocal Optics First Intervention (1 week) Second Intervention (1 week) | 22 |
| Total | 45 |
Baseline characteristics
| Characteristic | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Continuous | 21.87 years STANDARD_DEVIATION 3.37 | 22.5 years STANDARD_DEVIATION 3.01 | 22.17 years STANDARD_DEVIATION 3.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 18 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 16 Participants | 37 Participants |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 19 Participants | 16 Participants | 35 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
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.
Time frame: 1 week
Population: Outcome measures reported for both groups combined secondary to crossover design.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Multifocal Optics First, Then Single Vision Optics | Subject Reported Eye Fatigue | Single Vision | 18 units on a scale |
| Multifocal Optics First, Then Single Vision Optics | Subject Reported Eye Fatigue | Multifocal | 17 units on a scale |
| Single Vision Optics First, Then Multifocal Optics | Subject Reported Eye Fatigue | Single Vision | 21 units on a scale |
| Single Vision Optics First, Then Multifocal Optics | Subject Reported Eye Fatigue | Multifocal | 21.5 units on a scale |
| Total | Subject Reported Eye Fatigue | Single Vision | 21 units on a scale |
| Total | Subject Reported Eye Fatigue | Multifocal | 20 units on a scale |
Comparison: Ho: Single Vision - Multifocal \>= M vs. Ho: Single Vision - Multifocal \< M. Alpha = 0.05, two sided beta = 0.80p-value: 0.18t-test, 1 sided