Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TearScience, Inc.
ClinicalTrials.gov Identifier:
NCT00832130
First received: January 27, 2009
Last updated: December 5, 2011
Last verified: December 2011
Results First Received: September 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chalazion
Dry Eye Syndromes
Interventions: Device: Manual Mini System
Device: iHeat Portable Warm Compress Therapy

  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
A total of 139 subjects (278 eyes) were enrolled at nine clinical sites between 03/04/2009 and 05/14/2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At the 2 Week visit, Control subjects stopped the warm compress therapy and received a single Manual Mini (LipiFlow) crossover treatment.

Reporting Groups
  Description
Manual Mini System Treatment with experimental Manual Mini System
Warm Compress Therapy Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase

Participant Flow:   Overall Study
    Manual Mini System     Warm Compress Therapy  
STARTED     69     70  
COMPLETED     69     70  
NOT COMPLETED     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
Manual Mini System Treatment with experimental Manual Mini System
Warm Compress Therapy Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
Total Total of all reporting groups

Baseline Measures
    Manual Mini System     Warm Compress Therapy     Total  
Number of Participants  
[units: participants]
  69     70     139  
Age  
[units: Years]
Mean ± Standard Deviation
  52.4  ± 14.6     54.4  ± 16.4     53.4  ± 15.5  
Gender  
[units: participants]
     
Female     44     53     97  
Male     25     17     42  



  Outcome Measures
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1.  Primary:   Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)   [ Time Frame: Baseline, 2 Weeks and 4 Weeks ]

2.  Primary:   Incidence of Device-related Adverse Events   [ Time Frame: Baseline through 4 Weeks ]

3.  Primary:   Tear Break-up Time   [ Time Frame: Baseline, 2 Weeks and 4 Weeks ]

4.  Secondary:   Dry Eye Symptoms (Total SPEED Score)   [ Time Frame: Baseline, 2 Weeks and 4 Weeks ]

5.  Secondary:   Ocular Surface Staining (Corneal Staining Sum Score)   [ Time Frame: Baseline through 4 Weeks ]

6.  Secondary:   Intraocular Pressure   [ Time Frame: Baseline through 4 Weeks ]

7.  Secondary:   (LogMAR) Best Spectacle Corrected Visual Acuity   [ Time Frame: Baseline, 2 Weeks and 4 Weeks ]

8.  Secondary:   Discomfort Evaluation (Discomfort/Pain Score)   [ Time Frame: Treatment and 1 Day ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Christy Stevens, OD
Organization: TearScience, Inc. (formerly Kolis Scientific)
phone: 919-459-4815
e-mail: cstevens@tearscience.com


No publications provided


Responsible Party: TearScience, Inc.
ClinicalTrials.gov Identifier: NCT00832130     History of Changes
Other Study ID Numbers: LF001
Study First Received: January 27, 2009
Results First Received: September 19, 2011
Last Updated: December 5, 2011
Health Authority: United States: Institutional Review Board