Meibomian Gland Dysfunction Management With ZEST Protocol
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|ClinicalTrials.gov Identifier: NCT03968731|
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Meibomian Gland Dysfunction Dry Eye Syndromes Ocular Surface Disease||Other: Zocular Eyelid System Treatment||Not Applicable|
Meibomian gland dysfunction (MGD) is a common clinical condition seen in optometric practices that affects the quality of the tear fluid on the surface of the eye. In MGD, the Meibomian glands secrete lipids which are of poor quality and altered composition. This results in a dysfunctional tear fluid causing symptoms of ocular irritation (such as dry eyes). Patients who use contact lenses on a daily basis suffer from contact lens intolerance due to their MGD.
A study done by Korb and Blackie in 2013 demonstrated that manual debridement of the lid margin using a spatula is a viable management option for MGD and blepharitis. The investigators of this proposed study have researched the effect of debridement of lid debris (Either electronic debridement with BlephEx or manual debridement using a golf spud) in relieving signs and symptoms of blepharitis (which comprises MGD as well) in patients who do not wear contact lenses on a daily basis as well as in patients who wear contact lenses on a daily basis. The investigators obtained positive results from those studies. Signs and symptoms of MGD and Blepharitis improved in patients following lid margin debridement treatments. The ZEST protocol offers an alternate paradigm for cleaning the eyelid margins. The Zocular products contains okra-infused Zocusome micelles that gently lift and clear the oil, debris, and residue on eyelid margins Presumably, the ZEST treatment protocol will benefit patients who use contact lenses on a daily basis and suffer from symptoms of lens intolerance, since similar treatment / cleaning of lid margin debris has shown to be beneficial for these patients.
Therefore, this study will investigate if the ZEST protocol can relieve symptoms of contact lens intolerance caused by MGD.
There are no clinical studies using the ZEST protocol for the betterment of contact lens comfort in patients who have MGD. Hence, the proposed study will provide new and useful information about this treatment option for managing contact lens intolerance due to MGD. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from intolerance to contact lens wear due to MGD.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Meibomian Gland Dysfunction Management With Zocular Eyelid System Treatment (ZEST) to Relieve Contact Lens Discomfort|
|Actual Study Start Date :||June 10, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: ZEST treatment
The study subjects will receive the ZEST treatment protocol (Zocular Eyelid System treatment) to treat Meibomian Gland Dysfunction causing Contact Lens discomfort symptoms.
Other: Zocular Eyelid System Treatment
Zocular products contain okra-infused Zocusome micelles that gently lift and clear the oil, debris, and residue on eyelid margins. THerefore, the ZEST treatment is expected to improve signs and symptoms of Meibomian gland dysfunction (MGD) and reduce Contact lens discomfort associated with MGD.
Other Name: ZEST
- Contact Lens Questionnaire score [ Time Frame: One month ]Contact Lens Dry Eye Questionnaire score (CLDEQ-8) ranging from 0 to 41 points. A score of zero points on the CLDEQ-8 will mean the patient is completely asymptomatic whereas a score of 41 points will mean the patient is highly symptomatic for Contact Lens discomfort.
- Dry Eye Questionnaire score [ Time Frame: One month ]Ocular Surface Disease Index (OSDI) score ranging from 0 to 48 points. A score of zero on the OSDI will mean the patient does not have any dry eye symptoms whereas a score of 48 will mean that the patient is highly symptomatic for dry eye.
- MMP-9 expression [ Time Frame: One month ]Matrix Metalloproteinase-9 expression
- Tear break-up time [ Time Frame: One month ]Non-invasive tear break-up time
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): NCT03968731
|Contact: Mary Jo Bilicek||(210) email@example.com|
|United States, Texas|
|Rosenberg School of Optometry||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Srihari Narayanan, OD, PhD 210-283-6800 firstname.lastname@example.org|
|Principal Investigator:||Srihari Narayanan, OD, PhD||University of the Incarnate Word|