Asthenopia
Conditions
Keywords
Contact Lens, Multifocal, Accommodation, Presbyopia
Brief summary
This study will determine how multifocal contact lens correction affects symptoms of discomfort and asthenopia in a group of myopic contact lens wearers in the non-presbyopic age range (ages 30-40 years).
Detailed description
The purpose of this study is to determine how multifocal contact lenses affect contact lens comfort in non-presbyopic contact lens wearers. Current soft contact lens wearers who have symptoms of discomfort in their contact lenses will be recruited. Each subject (n = 84) will wear a single vision soft contact lens (Ultra single vision spherical lens) for two weeks and a low add power multifocal (Ultra for Presbyopia) for two weeks. Half of the subjects will wear the single vision lens first, and half of the subjects will wear the multifocal lens first. Initial lens group will be chosen randomly. Subjects will complete surveys that assess their vision and comfort which each lens, and ocular surface and accommodative/binocular vision status will be evaluated at the initial dispense and after wearing each lens for two weeks.
Interventions
DEVICEMultifocal Contact Lens
The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
Sponsors
Bausch & Lomb Incorporated
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Visual acuity of 20/25 or better in both eyes with habitual contact lenses * -0.75 D or more myopic in both eyes * -0.75 D or less astigmatism in both eyes * Current single vision contact lens wearer who does not require a reading aid * CLDEQ-8 score of 12 or more points with habitual contact lenses * No history of ocular surgery or medication * Reports digital device use of at least 3 hours per day * No significant signs of dry eye (grade 1 or less ocular surface staining, Schirmer score of 7 mm or more, and tear break up time of 7 seconds or more in bother eyes) * No significant binocular vision disorders in both eyes (eso or exophoria of 4 prism diopters or less at distance and near, near point of convergence of 6 mm or less, no history of strabismus or patching)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal) | After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Vision First Subjects in this group will receive the single vision spherical (Bausch + Lomb ULTRA®) lens for the first two weeks and be crossed over to the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lens for the second two weeks.
Single Vision First, Multifocal Second: The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks first, then the multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks | 42 |
| Multifocal First Subjects in this group will receive the multifocal (Bausch + Lomb ULTRA® for Presbyopia) lenses for the first two weeks and be crossed over to the single vision spherical (Bausch + Lomb ULTRA®) lens for the second two weeks.
Multifocal First, Single Vision Second: The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks first, then the single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Total | Multifocal First | Single Vision First |
|---|---|---|---|
| Accommodative Lag with 2 Diopter Target | 0.9 diopters STANDARD_DEVIATION 0.6 | 0.8 diopters STANDARD_DEVIATION 0.7 | 0.9 diopters STANDARD_DEVIATION 0.5 |
| Accommodative Lag with 4 Diopter Target | 1.4 diopters STANDARD_DEVIATION 0.8 | 1.5 diopters STANDARD_DEVIATION 0.7 | 1.3 diopters STANDARD_DEVIATION 0.9 |
| Age, Continuous | 34.4 years STANDARD_DEVIATION 3.2 | 34.5 years STANDARD_DEVIATION 3.1 | 34.4 years STANDARD_DEVIATION 3.4 |
| Contact Len Dry Eye Questionnaire-8 (CLDEQ-8) Score with Habitual Contact Lenses | 19.0 scores on a scale STANDARD_DEVIATION 4.7 | 19.1 scores on a scale STANDARD_DEVIATION 5 | 19.0 scores on a scale STANDARD_DEVIATION 4.5 |
| Race/Ethnicity, Customized Race/Ethnicity Data Not Collected for This Study | 0 Participants | — | — |
| Sex: Female, Male Female | 0 Participants | — | — |
| Sex: Female, Male Male | 0 Participants | — | — |
| Spherical Equivalent Refractive Error (Left Eye) | -4.2 diopters STANDARD_DEVIATION 2 | -4.1 diopters STANDARD_DEVIATION 2 | -4.2 diopters STANDARD_DEVIATION 2 |
| Spherical Equivalent Refractive Error (Right Eye) | -4.1 diopters STANDARD_DEVIATION 2.1 | -4.0 diopters STANDARD_DEVIATION 2 | -4.2 diopters STANDARD_DEVIATION 2.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 84 | 0 / 84 |
| other Total, other adverse events | 0 / 84 | 0 / 84 |
| serious Total, serious adverse events | 0 / 84 | 0 / 84 |
Outcome results
Primary
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score
After wearing each lens type (single vision and multifocal) for 2 weeks, subjects will complete the CLDEQ-8, a survey that assesses symptoms of contact lens discomfort, to reports their symptoms of discomfort with each lens type. CLDEQ-8 scores with the multifocal will be compared to CLDEQ-8 scores of the single vision lens and the subjects' habitual contact lenses to determine if the multifocal improved comfort. Min-Max CLDEQ-8 range: 0-37 points Higher point values indicate more/worse symptoms
Time frame: Baseline and after 2 weeks of contact lens wear with each study lens (single vision and multifocal)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CLDEQ-8 With Multifocal Contact Lens | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | 14.3 scores on a scale | Standard Deviation 7.1 |
| CLDEQ-8 With Single Vision Contact Lens | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | 12.8 scores on a scale | Standard Deviation 6.6 |
| CLDEQ-8 With Habitual Contact Lenses | Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score | 19.0 scores on a scale | Standard Deviation 4.7 |
Comparison: Generalized linear models (controlling for repeated measures) of crossover analyses was run to compare mean CLDEQ-8 scores with habitual, multifocal, and single vision contact lenses (controlling for order)p-value: <0.001Generalized linear models
Comparison: A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and refractive error (continuous, mean binocular spherical equivalent)p-value: 0.5Generalized linear model
Comparison: A generalized linear model was run to determine if there was an interaction between magnitude in accommodative lag (measured in diopters with a 2 diopter visual target) and lens type (single vision or multifocal)p-value: 0.7Generalized linear model
Comparison: A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (continuous, measured in self-reported years)p-value: 0.3Generalized linear model
Comparison: A generalized linear model was run to determine if there was an interaction between lens type (single vision or multifocal) and age (measured categorically as 30 to \<35 years old and 35 to 40 years old, by self report)p-value: 0.047Generalized linear model