An interventional study of Test Daily Disposable Soft Contact Lenses and Control Daily Disposable Soft Contact Lenses in Asthenopia, Contact Lenses and Ocular Accommodation, sponsored by State University of New York College of Optometry. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.
Sponsored by State University of New York College of Optometry · Not applicable, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.
This study's enrollment of 23 is below the median of 56 across 56 interventional studies indexed under Asthenopia.
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Exclusion Criteria:
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.
Device: Test Daily Disposable Soft Contact Lenses · Device: Control Daily Disposable Soft Contact Lenses
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.
Device: Test Daily Disposable Soft Contact Lenses · Device: Control Daily Disposable Soft Contact Lenses
Worn daily for 7 +/- 2 days
Worn daily for 7 +/- 2 days
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.
Lens Preference
Based on two alternative forced choice method
Time frame: 2 weeks
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
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
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
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Measured via Modified Thorington
Time frame: 1 week
| Milestone | Test 1 Week, Followed by Control 1 Week, no Washout | Control 1 Week, Followed by Test 1 Week, no Washout |
|---|---|---|
| Started | 12 | 11 |
| Completed | 12 | 10 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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).
| score on a scale | Test Arm: Multifocal Soft Contact Lenses | Control Arm: Single Vision Spherical Contact Lenses | Baseline Symptoms |
|---|---|---|---|
| Subjective Symptom Improvement | 153.9 ± 124.9 | 100.7 ± 79.2 | 272.13 ± 150.19 |
Based on two alternative forced choice method
| Participants | Preferred Multifocal Lenses | Preferred Single Vision Lenses |
|---|---|---|
| Lens Preference | 7 | 15 |
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.
| Diopters | Test Arm: Multifocal Soft Contact Lenses | Control Arm: Single Vision Spherical Contact Lenses |
|---|---|---|
| Lag at 25 cm | 1.52 ± 0.47 | 1.23 ± 0.57 |
| Lag at 40 cm | 1.06 ± 0.60 | 0.75 ± 0.45 |
| Lag at Distance | 0.00 ± 0.43 | 0.22 ± 0.44 |
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.
| score on a scale | Test Arm: Multifocal Soft Contact Lenses | Control Arm: Single Vision Spherical Contact Lenses |
|---|---|---|
| Convergence Insufficiency Symptom Survey (CISS) | 11.2 ± 6.8 | 10.8 ± 5.6 |
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).
| score on a scale | Test Arm: Multifocal Soft Contact Lenses | Control Arm: Single Vision Spherical Contact Lenses |
|---|---|---|
| Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) | 11.7 ± 6.4 | 11.0 ± 4.7 |
Measured via Modified Thorington
| Prism Diopters of Exophoria | Test Arm: Multifocal Soft Contact Lenses | Control Arm: Single Vision Spherical Contact Lenses |
|---|---|---|
| Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens | 2.3 ± 3.8 | 2.0 ± 4.5 |
| Participants | Phoria in Single Vision Spherical Contact Lenses |
|---|---|
| Esophoria at Near | 5 |
| Exophoria/ Orthophoria at Near | 17 |
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.
| Participants | Esophoric at Near | Exophoric or Orthophoria at Near |
|---|---|---|
| Preferred Multifocal Contact Lenses | 5 | 2 |
| Preferred Single Vision Contact Lenses | 0 | 15 |
Collected over Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multifocal Contact Lenses | 0/22 (0%) | 0/22 (0%) | 2/22 (9.1%) |
| Single Vision Contact Lenses | 0/23 (0%) | 0/23 (0%) | 1/23 (4.3%) |
| Event | Multifocal Contact Lenses | Single Vision Contact Lenses |
|---|---|---|
| Cold Like SymptomsRespiratory, thoracic and mediastinal disorders | 1/22 | 0/23 |
| Subcojnunctival HemorrhageEye disorders | 1/22 | 0/23 |
| Conjunctival HyperemiaEye disorders | 0/22 | 1/23 |
| Age, Continuous(years) | Test Followed by Control | Control Followed by Test | Total |
|---|---|---|---|
| Mean | 28.83 ± 3.63 | 25.09 ± 3.48 | 27.04 ± 3.97 |
| Sex: Female, Male(Participants) | Test Followed by Control | Control Followed by Test | Total |
|---|---|---|---|
| Female | 9 | 10 | 19 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Test Followed by Control | Control Followed by Test | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 12 | 11 | 23 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Test Followed by Control | Control Followed by Test | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 7 | 5 | 12 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Test Followed by Control | Control Followed by Test | Total |
|---|---|---|---|
| United States | 12 | 11 | 23 |
PDFs hosted by the registry, ClinicalTrials.gov.
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State University of New York College of Optometry