An interventional study of Zocular Eyelid System Treatment in Meibomian Gland Dysfunction, Dry Eye Syndromes and Ocular Surface Disease, sponsored by University of the Incarnate Word. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-14.
Sponsored by University of the Incarnate Word · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate if cleaning the eyelid margin with the ZEST protocol (Zocular Eyelid System Treatment) in patients intolerant to contact lens wear consequent to Meibomian gland dysfunction (MGD) will improve the MGD and contact lens wear comfort.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University of the Incarnate Word is the lead sponsor of 15 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Also known as: ZEST
Contact Lens Questionnaire score
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.
Time frame: One month
Dry Eye Questionnaire score
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.
Time frame: One month
MMP-9 expression
Matrix Metalloproteinase-9 expression
Time frame: One month
Tear break-up time
Non-invasive tear break-up time
Time frame: One month
Plan to share: No — IPD will not be shared with other outside researchers.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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University of the Incarnate Word