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Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Finis, MD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01769105
First received: January 11, 2013
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: September 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Meibomian Gland Dysfunction
Interventions: Device: Lipiflow
Behavioral: Lid hygiene regime

  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
Five patients had been enrolled in the study, but withdrew their participation after baseline examination for personal reasons. They did not receive any treatment.

Reporting Groups
  Description
Standard Lid Hygiene Regime First, Then Lipiflow

Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow

Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment

Lipiflow

Patients receive a singe Lipiflow-treatment

Lipiflow: Patients receive a single Lipiflow-treatment


Participant Flow for 2 periods

Period 1:   First Intervention
    Standard Lid Hygiene Regime First, Then Lipiflow     Lipiflow  
STARTED     16     19  
COMPLETED     14     17  
NOT COMPLETED     2     2  
Protocol Violation                 2                 2  

Period 2:   Cross-over
    Standard Lid Hygiene Regime First, Then Lipiflow     Lipiflow  
STARTED     14     0 [1]
COMPLETED     9     0 [2]
NOT COMPLETED     5     0  
Lost to Follow-up                 5                 0  
[1] Cross-over was only intended for the Lid margin hygiene group
[2] Was not intended by the study protocol



  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.
No text entered.

Reporting Groups
  Description
Standard Lid Hygiene Regime First, Then Lipiflow

Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow

Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment

Lipiflow

Patients receive a singe Lipiflow-treatment

Lipiflow: Patients receive a single Lipiflow-treatment

Total Total of all reporting groups

Baseline Measures
    Standard Lid Hygiene Regime First, Then Lipiflow     Lipiflow     Total  
Number of Participants  
[units: participants]
  14     17     31  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 19     45  ± 23     47  ± 21  
Gender  
[units: participants]
     
Female     10     12     22  
Male     4     5     9  
Region of Enrollment  
[units: participants]
     
Germany     14     17     31  



  Outcome Measures
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1.  Primary:   Change of Dry Eye Symptoms   [ Time Frame: after 3 month compared to baseline value ]

2.  Secondary:   Change of Break-up-time   [ Time Frame: after 3 month compared to baseline value ]

3.  Secondary:   Change in Tear Film Osmolarity   [ Time Frame: after 3 month compared to baseline value ]

4.  Secondary:   Change in Lipid Layer Thickness   [ Time Frame: after 3 month compared to baseline value ]

5.  Secondary:   Change in Expressible Meibomian Glands   [ Time Frame: after 3 month compared to baseline value ]


  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
For further information please have a look at Finis et al: Evaluation of an automated thermodynamic treatment (LipiFlow®) system for meibomian gland dysfunction: a prospective, randomized, observer-masked trial.Ocul Surf. 2014 Apr;12(2):146-54.


  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. David Finis
Organization: Department of ophthalmology, University of Duesseldorf
phone: +49 211 8117320
e-mail: David.Finis@med.uni-duesseldorf.de


Publications of Results:

Responsible Party: David Finis, MD, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01769105     History of Changes
Other Study ID Numbers: HHUAU052012
Study First Received: January 11, 2013
Results First Received: September 1, 2014
Last Updated: October 6, 2014
Health Authority: Germany: Ethics Commission