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Controlled Adverse Environment: A Pilot Study to Evaluate Tear Film Stability and Tear Evaporation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448356
First Posted: October 7, 2011
Last Update Posted: December 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Singapore National Eye Centre
Information provided by (Responsible Party):
Andrea Petznick, PhD, Singapore Eye Research Institute
Results First Submitted: July 17, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Environmental Exposure
Intervention: Procedure: temperature and humidity

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Temperature and Humidity All conditions were tested in a CAE chamber on the same day.

Participant Flow:   Overall Study
    Temperature and Humidity
STARTED   10 
COMPLETED   10 [1] 
NOT COMPLETED   0 
[1] cross-over



  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.
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Reporting Groups
  Description
Temperature and Humidity All conditions were tested in a CAE chamber on the same day.

Baseline Measures
   Temperature and Humidity 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.4  (1.3) 
Gender 
[Units: Participants]
 
Female   9 
Male   1 
Region of Enrollment 
[Units: Participants]
 
Singapore   10 


  Outcome Measures
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1.  Primary:   Tear Evaporation Rate   [ Time Frame: 20 minutes after the required temperature and humidity in the chamber is achieved ]

2.  Secondary:   Tear Film Break up Time   [ Time Frame: 20 minutes after the required temperature and humidity in the chamber is achieved ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Andrea Petznick
Organization: Singapore Eye Research Institute
phone: +65 6322 ext 4512
e-mail: andrea.petznick@seri.com.sg


Publications:

Responsible Party: Andrea Petznick, PhD, Singapore Eye Research Institute
ClinicalTrials.gov Identifier: NCT01448356     History of Changes
Other Study ID Numbers: R857/52/2011
2011/197/A ( Other Identifier: Singhealth Centralised Institutional Review Board )
First Submitted: October 4, 2011
First Posted: October 7, 2011
Results First Submitted: July 17, 2012
Results First Posted: December 12, 2012
Last Update Posted: December 12, 2012