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

This study has been completed.
Sponsor:
Collaborator:
Singapore National Eye Centre
Information provided by (Responsible Party):
Andrea Petznick, PhD, Singapore Eye Research Institute
ClinicalTrials.gov Identifier:
NCT01448356
First received: October 4, 2011
Last updated: November 14, 2012
Last verified: November 2012
Results First Received: July 17, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Environmental Exposure
Intervention: Procedure: temperature and humidity

  Participant Flow
  Hide Participant Flow

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
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
  Hide 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.
No text entered.

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

Baseline Measures
    Temperature and Humidity  
Number of Participants  
[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
  Show All Outcome Measures

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


  More Information
  Hide More Information

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


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
No text entered.  


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
Study First Received: October 4, 2011
Results First Received: July 17, 2012
Last Updated: November 14, 2012
Health Authority: Singapore: Health Sciences Authority