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Meibomian Gland Dysfunction Management

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.
 
ClinicalTrials.gov Identifier: NCT03652337
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
American Academy of Optometry
Information provided by (Responsible Party):
University of the Incarnate Word

Brief Summary:
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to Meibomian gland dysfunction.

Condition or disease Intervention/treatment Phase
Contact Lens Discomfort Meibomian Gland Dysfunction Device: BlephEx Device: Manual debridement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: BlephEx
The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.
Device: BlephEx
Electronic lid margin debridement

Experimental: Manual debridement
The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.
Device: Manual debridement
Manual lid margin debridement




Primary Outcome Measures :
  1. Symptomatic relief [ Time Frame: 60 days ]
    Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).


Secondary Outcome Measures :
  1. Meibography [ Time Frame: 60 days ]
    Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.

  2. Lissamine green staining grade of the lid margin [ Time Frame: 60 days ]
    The lid margin will be stained with Lissamine green dye. For the purpose of this study, Lissamine green staining of the eyelid margins will be graded from 0 to 4. (Zero representing "normal" or "no" staining; Four representing the highest degree of staining). During the course of the study, a decrease in lid margin staining will indicate a betterment of the health of the eyelid margin.

  3. Inflammatory activity [ Time Frame: 60 days ]
    The presence or absence of Matrix Metalloproteinase-9 (MMP-9) in the tear fluid will be documented during the study visits. Presence of MMP-9 in the tear fluid indicates the presence of inflammatory activity in the tear fluid.

  4. Tear break-up time [ Time Frame: 60 days ]
    Improvement in non-invasive tear break-up time measurement will be an objective outcome of the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.

Exclusion Criteria:

  • Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
  • Subjects who have active ocular infections will be excluded from participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652337


Locations
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United States, Texas
Rosenberg School of Optometry
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
University of the Incarnate Word
American Academy of Optometry
Investigators
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Principal Investigator: Srihari Narayanan, OD, PhD Professor

Publications of Results:
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Responsible Party: University of the Incarnate Word
ClinicalTrials.gov Identifier: NCT03652337    
Other Study ID Numbers: 18-04-003
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes