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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 : May 15, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Period 1
    Etafilcon A/ Etafilcon A for Astigmatism   Etafilcon A for Astigmatism/Etafilcon A
STARTED   58   56 
Habitual Users   51   52 
Neophtyes   7   4 
COMPLETED   55   51 
NOT COMPLETED   3   5 
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 2:   Period 2
    Etafilcon A/ Etafilcon A for Astigmatism   Etafilcon A for Astigmatism/Etafilcon A
STARTED   55   51 
Habitual Users   48   47 
Neophytes   7   4 
COMPLETED   53   51 
NOT COMPLETED   2   0 
Lens Discomfort                1                0 
Unsatisfactory Lens Fit                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis population consists of all subjects that were dispensed at least one study lens.

Reporting Groups
  Description
Dispensed Subjects All subjects that were dispensed at least one study lens.

Baseline Measures
   Dispensed Subjects 
Overall Participants Analyzed 
[Units: Participants]
 114 
Age 
[Units: Years]
Mean (Standard Deviation)
 
Habitual Users   26.9  (4.93) 
Neophtyes   28.5  (2.66) 
Overall   27.1  (4.77) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
 
Female      75  65.8% 
Male      39  34.2% 
[1] All subjects that were dispensed a study lens.
Race/Ethnicity, Customized 
[Units: 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 
[Units: Participants]
 
United States   114 


  Outcome Measures

1.  Primary:   Objective Comfort Assessed by Electromyography(EMG)   [ Time Frame: 1 week ]

2.  Primary:   Visual Comfort   [ Time Frame: 1-week follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Data collected on Neophyte population was for exploratory purpose only. The study was not powered to show differences in this population.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: KOSBORN@its.jnj.com



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: May 15, 2017