Non-invasive Ocular Surface Measurements Before and After Interventions

This study has been terminated.
(The study was terminated.)
Sponsor:
Information provided by (Responsible Party):
James V. Aquavella, MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01228929
First received: October 25, 2010
Last updated: September 17, 2015
Last verified: September 2015
Results First Received: July 31, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Dry Eye Syndrome
Healthy
Intervention: Other: Environmental Chamber Condition Change Intervention

  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
Normal Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
Aqueous Deficiency Dry Eye (ADDE) Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
Meibomian Gland Dysfunction (MGD) Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.

Participant Flow for 3 periods

Period 1:   Nominal Condition
    Normal     Aqueous Deficiency Dry Eye (ADDE)     Meibomian Gland Dysfunction (MGD)  
STARTED     6     6     6  
COMPLETED     6     6     6  
NOT COMPLETED     0     0     0  

Period 2:   Low Humidity Condition
    Normal     Aqueous Deficiency Dry Eye (ADDE)     Meibomian Gland Dysfunction (MGD)  
STARTED     6     6     6  
COMPLETED     6     6     6  
NOT COMPLETED     0     0     0  

Period 3:   High Temperature Condition
    Normal     Aqueous Deficiency Dry Eye (ADDE)     Meibomian Gland Dysfunction (MGD)  
STARTED     6     6     6  
COMPLETED     6     6     6  
NOT COMPLETED     0     0     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.
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Reporting Groups
  Description
Normal Subjects with no clinical diagnosis or symptoms of dry eye.
Aqueous Deficiency Dry Eye (ADDE) Subjects with low tear volume measured by Schirmer's test less than 10 mm.
Meibomian Gland Dysfunction (MGD) Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
Total Total of all reporting groups

Baseline Measures
    Normal     Aqueous Deficiency Dry Eye (ADDE)     Meibomian Gland Dysfunction (MGD)     Total  
Number of Participants  
[units: participants]
  6     6     6     18  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     6     6     6     18  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     4     2     3     9  
Male     2     4     3     9  
Region of Enrollment  
[units: participants]
       
United States     6     6     6     18  



  Outcome Measures

1.  Primary:   Change in Ocular Surface Temperature (OST)   [ Time Frame: baseline and 30 minutes ]


  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. James V. Aquavella
Organization: University of Rochester
phone: 585-275-8944
e-mail: james_aquavella@urmc.rochester.edu



Responsible Party: James V. Aquavella, MD, University of Rochester
ClinicalTrials.gov Identifier: NCT01228929     History of Changes
Other Study ID Numbers: 32315
Study First Received: October 25, 2010
Results First Received: July 31, 2015
Last Updated: September 17, 2015
Health Authority: United States: Food and Drug Administration