Meibomian Gland Dysfunction Management With ZEST Protocol

Meibomian Gland Dysfunction Management With Zocular Eyelid System Treatment (ZEST) to Relieve Contact Lens Discomfort

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes; Meibomian Gland Dysfunction; Ocular Surface Disease
• Intervention / Treatment: Other: Zocular Eyelid System Treatment

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Rosenberg School of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinically determined presence of Meibomian gland dysfunction
• Patient Self-reported discomfort with contact lens wear
• Use of contact lenses on a daily basis

Exclusion Criteria:

• Subjects should not be under active medical treatment for MGD or Blepharitis (inflammation of the eyelid margins) as this will negate the effects of the treatment offered in the proposed study.
• Subjects should not be using prescription eye drops for any reason. Subjects should not be taking any systemic Anti-inflammatory or anti-biotic medication during the course of the study as these medications can alter the effects of the treatment offered in the proposed study.
• Subjects should not have received any form of eyelid margin debridement (such as BlephEx or Manual debridement or ZEST treatment) in the sixty days prior to start of the study as the study treatment will be redundant and no benefits may be perceived by the subject.
• Subjects cannot participate in this study if they are allergic to Okra or Okra-based products (since Zocular products contain an extract from the Okra plant).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: ZEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	One month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MMP-9 expression	Matrix Metalloproteinase-9 expression	One month
Tear break-up time	Non-invasive tear break-up time	One month

Collaborators and Investigators

• Sponsor: University of the Incarnate Word
• Investigators: Principal Investigator: Srihari Narayanan, OD, PhD, University of the Incarnate Word

Publications and helpful links

General Publications

• Korb DR, Blackie CA. Debridement-scaling: a new procedure that increases Meibomian gland function and reduces dry eye symptoms. Cornea. 2013 Dec;32(12):1554-7. doi: 10.1097/ICO.0b013e3182a73843.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: May 28, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: contact lens discomfort
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Dry Eye Syndromes; Meibomian Gland Dysfunction
• Other Study ID Numbers: 19-05-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared with other outside researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No