Meibomian Gland Dysfunction Management
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|ClinicalTrials.gov Identifier: NCT03652337|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Contact Lens Discomfort Meibomian Gland Dysfunction||Device: BlephEx Device: Manual debridement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.
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
- 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).
- Meibography [ Time Frame: 60 days ]Meibomian gland imaging will be performed to document any changes in the Meibomian gland during the study period.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652337
|United States, Texas|
|Rosenberg School of Optometry|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Srihari Narayanan, OD, PhD||Professor|