Trial Outcomes & Findings for Connecting Contact Lenses and Digital Technology (NCT NCT02921087)
NCT ID: NCT02921087
Last Updated: 2019-09-11
Results Overview
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).
COMPLETED
NA
23 participants
Baseline and after 1 week of wearing each lens.
2019-09-11
Participant Flow
Forty five subjects were consented and screened. Twenty three were found to be eligible and randomized. Twenty two completed the study.
Participant milestones
| Measure |
Test 1 Week, Followed by Control 1 Week, no Washout
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
|
Control 1 Week, Followed by Test 1 Week, no Washout
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Test 1 Week, Followed by Control 1 Week, no Washout
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
|
Control 1 Week, Followed by Test 1 Week, no Washout
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Connecting Contact Lenses and Digital Technology
Baseline characteristics by cohort
| Measure |
Test Followed by Control
n=12 Participants
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
|
Control Followed by Test
n=11 Participants
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
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.83 years
STANDARD_DEVIATION 3.63 • n=5 Participants
|
25.09 years
STANDARD_DEVIATION 3.48 • n=7 Participants
|
27.04 years
STANDARD_DEVIATION 3.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 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
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=22 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
n=22 Participants
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Subjective Symptom Improvement
|
153.9 score on a scale
Standard Deviation 124.9
|
100.7 score on a scale
Standard Deviation 79.2
|
272.13 score on a scale
Standard Deviation 150.19
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: 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.
Based on two alternative forced choice method
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=22 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Lens Preference
|
7 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=22 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Lag of Accommodation in Study Lenses
Lag at 25 cm
|
1.52 Diopters
Standard Deviation 0.47
|
1.23 Diopters
Standard Deviation 0.57
|
—
|
|
Lag of Accommodation in Study Lenses
Lag at 40 cm
|
1.06 Diopters
Standard Deviation 0.60
|
0.75 Diopters
Standard Deviation 0.45
|
—
|
|
Lag of Accommodation in Study Lenses
Lag at Distance
|
0.00 Diopters
Standard Deviation 0.43
|
0.22 Diopters
Standard Deviation 0.44
|
—
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=22 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Convergence Insufficiency Symptom Survey (CISS)
|
11.2 score on a scale
Standard Deviation 6.8
|
10.8 score on a scale
Standard Deviation 5.6
|
—
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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).
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=22 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
|
11.7 score on a scale
Standard Deviation 6.4
|
11.0 score on a scale
Standard Deviation 4.7
|
—
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
Measured via Modified Thorington
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=22 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual 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
|
2.0 Prism Diopters of Exophoria
Standard Deviation 4.5
|
—
|
POST_HOC outcome
Timeframe: 1 weekPopulation: Phoria at near as measured through the single vision spherical contact lenses
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=22 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Participants Stratified by Subjects' Near Phoria With Single Vision Lenses
Esophoria at Near
|
5 Participants
|
—
|
—
|
|
Participants Stratified by Subjects' Near Phoria With Single Vision Lenses
Exophoria/ Orthophoria at Near
|
17 Participants
|
—
|
—
|
POST_HOC outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Test Arm: Multifocal Soft Contact Lenses
n=5 Participants
Symptoms after one week of wearing multifocal soft spherical contact lenses.
|
Control Arm: Single Vision Spherical Contact Lenses
n=17 Participants
Symptoms after one week of wearing single vision soft spherical contact lenses.
|
Baseline Symptoms
Symptoms at visit one in habitual contact lenses
|
|---|---|---|---|
|
Phoria and Lens Preference
Preferred Multifocal Contact Lenses
|
5 Participants
|
2 Participants
|
—
|
|
Phoria and Lens Preference
Preferred Single Vision Contact Lenses
|
0 Participants
|
15 Participants
|
—
|
Adverse Events
Multifocal Contact Lenses
Single Vision Contact Lenses
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multifocal Contact Lenses
n=22 participants at risk
Adverse Events while wearing Multifocal Contact Lenses
|
Single Vision Contact Lenses
n=23 participants at risk
Adverse Events while wearing Single Vision Contact Lenses
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperemia
|
0.00%
0/22 • Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
|
4.3%
1/23 • Number of events 2 • Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cold Like Symptoms
|
4.5%
1/22 • Number of events 1 • Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
|
0.00%
0/23 • Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
|
|
Eye disorders
Subcojnunctival Hemorrhage
|
4.5%
1/22 • Number of events 1 • Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
|
0.00%
0/23 • Adverse events were collected throughout the study, which lasted for approximately 2 weeks per subject.
|
Additional Information
Danielle Iacono, OD
SUNY College of Optometry Clinical Vision Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place