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IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sensimed AG
ClinicalTrials.gov Identifier:
NCT01560975
First received: March 20, 2012
Last updated: November 18, 2014
Last verified: November 2014
Results First Received: November 18, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Sleep Apnea, Obstructive
Primary Open-angle Glaucoma
Intervention: Device: SENSIMED Triggerfish®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sensimed Triggerfish SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Participant Flow:   Overall Study
    Sensimed Triggerfish  
STARTED     10  
COMPLETED     10  
NOT COMPLETED     0  



  Baseline Characteristics
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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.
65.2

Reporting Groups
  Description
Sensimed Triggerfish SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours

Baseline Measures
    Sensimed Triggerfish  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean ± Standard Deviation
  65.2  ± 8.3  
Gender  
[units: participants]
 
Female     2  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures

1.  Primary:   Relationship Between IOP Fluctuation Pattern With or Without CPAP Therapy in Patients With Moderate to Severe OSAS With or Without POAG   [ Time Frame: 24 hours ]

2.  Secondary:   Relationship Between the 24-hour IOP Fluctuation Patterns and Physiologic Parameters, With or Without CPAP Therapy in Patients With Moderate to Severe OSAS, With or Without POAG   [ Time Frame: 24-hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Effect After CPAP Removal on the IOP Pattern   [ Time Frame: 30 min ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Dr. Robert Ritch
Organization: NYEE
phone: +1 212 477 7540
e-mail: ritchmd@earthlink.net


No publications provided


Responsible Party: Sensimed AG
ClinicalTrials.gov Identifier: NCT01560975     History of Changes
Other Study ID Numbers: TF-1108
Study First Received: March 20, 2012
Results First Received: November 18, 2014
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board