Asthenopia, Contact Lenses, Convergence, Excess, Ocular Accommodation
Conditions
Brief summary
This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.
Detailed description
This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.
Interventions
DEVICETest Daily Disposable Soft Contact Lenses
Worn daily for 7 +/- 2 days
DEVICEControl Daily Disposable Soft Contact Lenses
Worn daily for 7 +/- 2 days
Sponsors
Johnson & Johnson Vision Care, Inc.
State University of New York College of Optometry
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 to 35 years of age 2. Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder 3. Current single-vision soft contact lens wearer 4. Monocular acuity of 20/25 or better in each eye (Snellen) 5. Self-reported minimum of 6 hours a day on digital devices 6. Self-reported complaint of eyestrain on digital devices 7. No ocular pathology and/or history of eye surgery 8. No history of strabismus or strabismus surgery 9. No gas permeable lens wear for at least 3 months 10. Subjects may not be optometrists, opticians or optometry students
Exclusion criteria
1. Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale 2. Negative Relative Accommodation (NRA) less than +1.50 D 3. Exophoria at near \> 6 prism diopters10 4. Vertical phoria \> 1 prism diopter 5. Presence of tropia 6. Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8) 7. Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Symptom Improvement | Baseline and after 1 week of wearing each lens. | The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Preference | 2 weeks | Based on two alternative forced choice method |
| Lag of Accommodation in Study Lenses | 1 week | Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag. |
| Convergence Insufficiency Symptom Survey (CISS) | 1 week | Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60. |
| Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | 1 week | CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms). |
| Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | 1 week | Measured via Modified Thorington |
Countries
United States
Participant flow
Pre-assignment details
Forty five subjects were consented and screened. Twenty three were found to be eligible and randomized. Twenty two completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Test Followed by Control Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.
Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days
Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days | 12 |
| Control Followed by Test Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.
Test Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days
Control Daily Disposable Soft Contact Lenses: Worn daily for 7 +/- 2 days | 11 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Test Followed by Control | Total | Control Followed by Test |
|---|---|---|---|
| Age, Continuous | 28.83 years STANDARD_DEVIATION 3.63 | 27.04 years STANDARD_DEVIATION 3.97 | 25.09 years STANDARD_DEVIATION 3.48 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 23 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 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 | 7 Participants | 12 Participants | 5 Participants |
| Region of Enrollment United States | 12 participants | 23 participants | 11 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 2 / 22 | 1 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
Primary
Subjective Symptom Improvement
The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).
Time frame: Baseline and after 1 week of wearing each lens.
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. One week data for the primary outcome was available for 22 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Subjective Symptom Improvement | 153.9 score on a scale | Standard Deviation 124.9 |
| Control Arm: Single Vision Spherical Contact Lenses | Subjective Symptom Improvement | 100.7 score on a scale | Standard Deviation 79.2 |
| Baseline Symptoms | Subjective Symptom Improvement | 272.13 score on a scale | Standard Deviation 150.19 |
Comparison: In order to analyze the 2 x 2 crossover design for the primary outcome (change in overall VAS at day 7) mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.p-value: 0.07Mixed Models Analysis
Secondary
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).
Time frame: 1 week
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | 11.7 score on a scale | Standard Deviation 6.4 |
| Control Arm: Single Vision Spherical Contact Lenses | Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | 11.0 score on a scale | Standard Deviation 4.7 |
Comparison: In order to analyze the 2 x 2 crossover design for the CLDEQ-8, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.p-value: 0.69Mixed Models Analysis
Secondary
Convergence Insufficiency Symptom Survey (CISS)
Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.
Time frame: 1 week
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Convergence Insufficiency Symptom Survey (CISS) | 11.2 score on a scale | Standard Deviation 6.8 |
| Control Arm: Single Vision Spherical Contact Lenses | Convergence Insufficiency Symptom Survey (CISS) | 10.8 score on a scale | Standard Deviation 5.6 |
Comparison: In order to analyze the 2 x 2 crossover design for the change in CISS, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.p-value: 0.77Mixed Models Analysis
Secondary
Lag of Accommodation in Study Lenses
Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.
Time frame: 1 week
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Lag of Accommodation in Study Lenses | Lag at 25 cm | 1.52 Diopters | Standard Deviation 0.47 |
| Test Arm: Multifocal Soft Contact Lenses | Lag of Accommodation in Study Lenses | Lag at 40 cm | 1.06 Diopters | Standard Deviation 0.6 |
| Test Arm: Multifocal Soft Contact Lenses | Lag of Accommodation in Study Lenses | Lag at Distance | 0.00 Diopters | Standard Deviation 0.43 |
| Control Arm: Single Vision Spherical Contact Lenses | Lag of Accommodation in Study Lenses | Lag at 25 cm | 1.23 Diopters | Standard Deviation 0.57 |
| Control Arm: Single Vision Spherical Contact Lenses | Lag of Accommodation in Study Lenses | Lag at 40 cm | 0.75 Diopters | Standard Deviation 0.45 |
| Control Arm: Single Vision Spherical Contact Lenses | Lag of Accommodation in Study Lenses | Lag at Distance | 0.22 Diopters | Standard Deviation 0.44 |
Comparison: In order to analyze the 2 x 2 crossover design for accommodative response mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.p-value: 0.01Mixed Models Analysis
Secondary
Lens Preference
Based on two alternative forced choice method
Time frame: 2 weeks
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Lens Preference | 7 Participants |
| Control Arm: Single Vision Spherical Contact Lenses | Lens Preference | 15 Participants |
Secondary
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Measured via Modified Thorington
Time frame: 1 week
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Data was available for 22 subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | 2.3 Prism Diopters of Exophoria | Standard Deviation 3.8 |
| Control Arm: Single Vision Spherical Contact Lenses | Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | 2.0 Prism Diopters of Exophoria | Standard Deviation 4.5 |
Comparison: In order to analyze the 2 x 2 crossover design for phoria, mixed model analysis was utilized, allowing the sequences of each subject to be modeled as repeated measures within PROC Mixed.p-value: 0.87Mixed Models Analysis
Post Hoc
Participants Stratified by Subjects' Near Phoria With Single Vision Lenses
Time frame: 1 week
Population: Phoria at near as measured through the single vision spherical contact lenses
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Participants Stratified by Subjects' Near Phoria With Single Vision Lenses | Esophoria at Near | 5 Participants |
| Test Arm: Multifocal Soft Contact Lenses | Participants Stratified by Subjects' Near Phoria With Single Vision Lenses | Exophoria/ Orthophoria at Near | 17 Participants |
Post Hoc
Phoria and Lens Preference
Subjects' phoria at near with single vision lenses was classified as esophoric or exophoric. Lens preference was compared (multifocal vs single vision lenses) between the subjects who were esophoric at near vs the subjects who were exophoric/orthophoric at near.
Time frame: 1 week
Population: Forty five subjects were enrolled into the study. Twenty three eligible subjects were randomized. One subject discontinued early due to discomfort in the first lens assigned. Of the 22 completed subjects, 5 had an esophoria at near. 17 were exophoric or orthophoric at near.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Test Arm: Multifocal Soft Contact Lenses | Phoria and Lens Preference | Preferred Multifocal Contact Lenses | 5 Participants |
| Test Arm: Multifocal Soft Contact Lenses | Phoria and Lens Preference | Preferred Single Vision Contact Lenses | 0 Participants |
| Control Arm: Single Vision Spherical Contact Lenses | Phoria and Lens Preference | Preferred Multifocal Contact Lenses | 2 Participants |
| Control Arm: Single Vision Spherical Contact Lenses | Phoria and Lens Preference | Preferred Single Vision Contact Lenses | 15 Participants |