Trial Outcomes & Findings for Toric Eye Strain and Stability Study (NCT NCT01857102)
NCT ID: NCT01857102
Last Updated: 2018-06-19
Results Overview
Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.
COMPLETED
NA
159 participants
1 week
2018-06-19
Participant Flow
A total of 159 subjects were enrolled in the study. Of the enrolled subjects 45 did not meet the eligibility criteria and 114 subjects were dispensed a study lens. Of the dispensed subjects 10 subjects were discontinued and 94 subjects completed the study.
Of those completed 24 were excluded from the analysis due to a major protocol deviation. Of the subjects that completed all study visits without a major protocol deviation, 10 subjects were classified as neophytes and 60 as habitual contact lens users.
Participant milestones
| Measure |
Etafilcon A/ Etafilcon A for Astigmatism
Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens.
|
Etafilcon A for Astigmatism/Etafilcon A
Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
|
|---|---|---|
|
Period 1
STARTED
|
58
|
56
|
|
Period 1
Habitual Users
|
51
|
52
|
|
Period 1
Neophtyes
|
7
|
4
|
|
Period 1
COMPLETED
|
55
|
51
|
|
Period 1
NOT COMPLETED
|
3
|
5
|
|
Period 2
STARTED
|
55
|
51
|
|
Period 2
Habitual Users
|
48
|
47
|
|
Period 2
Neophytes
|
7
|
4
|
|
Period 2
COMPLETED
|
53
|
51
|
|
Period 2
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Etafilcon A/ Etafilcon A for Astigmatism
Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens.
|
Etafilcon A for Astigmatism/Etafilcon A
Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
|
|---|---|---|
|
Period 1
No longer meets Eligibility Criteria
|
0
|
2
|
|
Period 1
Lost to Follow-up
|
0
|
3
|
|
Period 1
Unsatisfactory Lens Fit
|
1
|
0
|
|
Period 1
Unsatisfactory Visual Response
|
1
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
|
Period 2
Lens Discomfort
|
1
|
0
|
|
Period 2
Unsatisfactory Lens Fit
|
1
|
0
|
Baseline Characteristics
Toric Eye Strain and Stability Study
Baseline characteristics by cohort
| Measure |
Dispensed Subjects
n=114 Participants
All subjects that were dispensed at least one study lens.
|
|---|---|
|
Age, Continuous
Habitual Users
|
26.9 years
STANDARD_DEVIATION 4.93 • n=5 Participants
|
|
Age, Continuous
Neophtyes
|
28.5 years
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
Age, Continuous
Overall
|
27.1 years
STANDARD_DEVIATION 4.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 weekPopulation: Analysis population consists of all subjects that completed all study visits without a major protocol deviation.
Electromyography (EMG) utilizes electrodes affixed to the skin below the eyelid, which measures activity of the orbital portion of the orbicularis oculi muscle. The orbital portion of the orbicularis oculi muscle pulls on the skin of the forehead, temple and cheek and draws it toward a point at the edge of the orbit. This part of the muscle is mainly under voluntary control, and it what is contracted during the process of squinting. The palpebral portion of this muscle closes the eyelids. The EMG reading was performed while the subject was wearing contact lenses in order to objectively assess eyestrain.The higher the EMG reading indicated the more the eyestrain. The original EMG data collected from a 40-second recording consisted of approximately 40,000 observations; the machine read about 1000 observations per second consecutively during 40-second recording. The original EMG reading was converted to a single data point and entered in the EDC for the analysis purpose.
Outcome measures
| Measure |
Etafilcon A
n=70 Participants
Subjects that received the etafilcon A lens in either the first or second period of the study.
|
Etafilcon A for Astigmatism
n=70 Participants
Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
|
|---|---|---|
|
Objective Comfort Assessed by Electromyography(EMG)
Habitual Users, N=60, N=60
|
0.082 volts
Standard Deviation 0.1239
|
0.047 volts
Standard Deviation 0.0599
|
|
Objective Comfort Assessed by Electromyography(EMG)
Neophytes, N=10, N=10
|
0.085 volts
Standard Deviation 0.0940
|
0.257 volts
Standard Deviation 0.6310
|
PRIMARY outcome
Timeframe: 1-week follow-upPopulation: The analysis population consists of all subjects that completed all study visits without a major protocol deviation.
The Visual comfort (diurnal fluctuation\[DF\]) scores were derived from the National Eye Institute Refractive Error Quality of Life (NEI-RQL) instruments- specifically the diurnal fluctuations sub-scale, by following the instruction given in the NEI-RQL-42 User Manual, Version 1.0. The NEI-RQL is a validated patient reported outcome questionnaire to assess the impact of refractive correction on vision specifically to quality of life. This survey consisted of 42 items used to develop 13 subscales: clarity of vision, expectations, near vision, far vision, diurnal fluctuations, activity limitations, glare, symptoms, dependence on correction, worry, suboptimal correction, appearance, and satisfaction with correction. An overall score is calculated by averaging the subscales. The overall scores can take on values of 0 to 100. Higher scores indicate better outcomes
Outcome measures
| Measure |
Etafilcon A
n=70 Participants
Subjects that received the etafilcon A lens in either the first or second period of the study.
|
Etafilcon A for Astigmatism
n=70 Participants
Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
|
|---|---|---|
|
Visual Comfort
Habitual Users, N=60, N=60
|
72.8 units on a scale
Standard Deviation 24.94
|
80.6 units on a scale
Standard Deviation 19.41
|
|
Visual Comfort
Nepohytes, N=10, N=10
|
70.4 units on a scale
Standard Deviation 21.29
|
72.5 units on a scale
Standard Deviation 23.02
|
Adverse Events
Etafilcon A
Etafilcon A for Astigmatism
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kathrine E. Osborn, OD, MS, FAAO- DIRECTOR GLOBAL STRATEGIC CLAIMS
Johnson and Johnson Vision Care Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60