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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01769105
First Posted: January 16, 2013
Last Update Posted: October 7, 2014
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.
Information provided by (Responsible Party):
David Finis, MD, Heinrich-Heine University, Duesseldorf
Results First Submitted: September 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
First Submitted: January 11, 2013
First Posted: January 16, 2013
Results First Submitted: September 1, 2014
Results First Posted: October 7, 2014
Last Update Posted: October 7, 2014



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