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Toric Eye Strain and Stability Study

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ClinicalTrials.gov Identifier: NCT01857102
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : May 15, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Astigmatism
Interventions Device: etafilcon A
Device: etafilcon A for Astigmatism
Enrollment 159
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Etafilcon A/ Etafilcon A for Astigmatism Etafilcon A for Astigmatism/Etafilcon A
Hide Arm/Group Description Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens. Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
Period Title: Period 1
Started 58 56
Habitual Users 51 52
Neophtyes 7 4
Completed 55 51
Not Completed 3 5
Reason Not Completed
No longer meets Eligibility Criteria             0             2
Lost to Follow-up             0             3
Unsatisfactory Lens Fit             1             0
Unsatisfactory Visual Response             1             0
Physician Decision             1             0
Period Title: Period 2
Started 55 51
Habitual Users 48 47
Neophytes 7 4
Completed 53 51
Not Completed 2 0
Reason Not Completed
Lens Discomfort             1             0
Unsatisfactory Lens Fit             1             0
Arm/Group Title Dispensed Subjects
Hide Arm/Group Description All subjects that were dispensed at least one study lens.
Overall Number of Baseline Participants 114
Hide Baseline Analysis Population Description
Analysis population consists of all subjects that were dispensed at least one study lens.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants
Habitual Users 26.9  (4.93)
Neophtyes 28.5  (2.66)
Overall 27.1  (4.77)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants
Female
75
  65.8%
Male
39
  34.2%
[1]
Measure Description: All subjects that were dispensed a study lens.
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants
American Indian or Alaska Native 3
Asian 34
Black or African American 18
Native Hawaiian or Pacific Islander 2
White 49
Other 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 114 participants
114
1.Primary Outcome
Title Objective Comfort Assessed by Electromyography(EMG)
Hide Description 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.
Time Frame 1 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis population consists of all subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Etafilcon A Etafilcon A for Astigmatism
Hide Arm/Group Description:
Subjects that received the etafilcon A lens in either the first or second period of the study.
Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
Overall Number of Participants Analyzed 70 70
Mean (Standard Deviation)
Unit of Measure: volts
Habitual Users, N=60, N=60 0.082  (0.1239) 0.047  (0.0599)
Neophytes, N=10, N=10 0.085  (0.0940) 0.257  (0.6310)
2.Primary Outcome
Title Visual Comfort
Hide Description 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
Time Frame 1-week follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of all subjects that completed all study visits without a major protocol deviation.
Arm/Group Title Etafilcon A Etafilcon A for Astigmatism
Hide Arm/Group Description:
Subjects that received the etafilcon A lens during the first or second period of the study.
Subjects that received etafilcon A for Astigmatism lens in either the first or second period of the study.
Overall Number of Participants Analyzed 70 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
Habitual Users, N=60, N=60 72.8  (24.94) 80.6  (19.41)
Nepohytes, N=10, N=10 70.4  (21.29) 72.5  (23.02)
Time Frame Throughout the duration of the study. Approximately 1 month per subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etafilcon A Etafilcon A for Astigmatism
Hide Arm/Group Description Subjects that received the etafilcon A lens in either the first or second period of the study. Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
All-Cause Mortality
Etafilcon A Etafilcon A for Astigmatism
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etafilcon A Etafilcon A for Astigmatism
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/114 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etafilcon A Etafilcon A for Astigmatism
Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/114 (0.00%) 
Data collected on Neophyte population was for exploratory purpose only. The study was not powered to show differences in this population.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kathrine E. Osborn, OD, MS, FAAO- DIRECTOR GLOBAL STRATEGIC CLAIMS
Organization: Johnson and Johnson Vision Care Inc.
Phone: 904-443-1032
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT01857102     History of Changes
Other Study ID Numbers: CR-5363
First Submitted: May 8, 2013
First Posted: May 20, 2013
Results First Submitted: July 19, 2016
Results First Posted: May 15, 2017
Last Update Posted: June 19, 2018