Meibomian Gland Dysfunction Management With ZEST Protocol

NCT03968731 | Completed

• 1 other identifier: 19-05-007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes; Ocular Surface Disease

Keywords

contact lens discomfort

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• MMP-9 expression

  One month

• Tear break-up time

  One month

Study Arms (1)

ZEST treatment

EXPERIMENTAL

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

Interventions

Zocular Eyelid System Treatment OTHER

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

ZEST treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of the Incarnate Word: lead

Study Sites (1)

Rosenberg School of Optometry

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 24145633 BACKGROUND

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Srihari Narayanan, OD, PhD

  University of the Incarnate Word

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: June 10, 2019
• Primary Completion: March 31, 2020
• Study Completion: May 31, 2020
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)