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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
Sponsor:
Information provided by (Responsible Party):
SRIHARI NARAYANAN, University of the Incarnate Word

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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Dry Eye Syndromes Ocular Surface Disease Other: Zocular Eyelid System Treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

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 Name: ZEST




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. MMP-9 expression [ Time Frame: One month ]
    Matrix Metalloproteinase-9 expression

  2. Tear break-up time [ Time Frame: One month ]
    Non-invasive tear break-up time



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Mary Jo Bilicek (210) 805-3565 bilicek@uiwtx.edu

Locations
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United States, Texas
Rosenberg School of Optometry Recruiting
San Antonio, Texas, United States, 78229
Contact: Srihari Narayanan, OD, PhD    210-283-6800    narayana@uiwtx.edu   
Sponsors and Collaborators
University of the Incarnate Word
Investigators
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Principal Investigator: Srihari Narayanan, OD, PhD University of the Incarnate Word

Publications:
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Responsible Party: SRIHARI NARAYANAN, Professor, University of the Incarnate Word
ClinicalTrials.gov Identifier: NCT03968731     History of Changes
Other Study ID Numbers: 19-05-007
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other outside researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by SRIHARI NARAYANAN, University of the Incarnate Word:
contact lens discomfort

Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases