Meibomian Gland DysfunctionNCT03968731
Meibomian Gland Dysfunction Management With ZEST Protocol
A study testing Zocular Eyelid System Treatment in people with Meibomian Gland Dysfunction and Dry Eye Syndromes, run by University of the Incarnate Word at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye Syndromes, Ocular Surface Disease
- What is being tested?
- Zocular Eyelid System Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically determined presence of Meibomian gland dysfunction
- Patient Self-reported discomfort with contact lens wear
- Use of contact lenses on a daily basis
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Rosenberg School of Optometry
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Being tested
- Zocular Eyelid System Treatment
- Keywords
- contact lens discomfort
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zocular Eyelid System TreatmentOther
Also called ZEST
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Zocular Eyelid System Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One month
Secondary outcomes (2)
MMP-9 expression
Matrix Metalloproteinase-9 expression
Measured: One month
Tear break-up time
Non-invasive tear break-up time
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start10 Jun 2019
- Primary completion31 Mar 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Incarnate Word
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SRIHARI NARAYANAN, University of the Incarnate Word
- Investigators
- Srihari Narayanan, OD, PhD, Principal investigator, University of the Incarnate Word
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968731
- Sponsor's protocol ID
- 19-05-007
- Status last verified
- Jul 2022
- First submitted
- 28 May 2019
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other outside researchers.
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.
PubMed 24145633
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meibomian Gland Dysfunction Management With Zocular Eyelid System Treatment (ZEST) to Relieve Contact Lens Discomfort
- ClinicalTrials.gov ID
- NCT03968731
- Acronym / sponsor ID
- 19-05-007
- Keywords
- contact lens discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of the Incarnate WordUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZEST treatment | Experimental | Other: Zocular Eyelid System TreatmentThe study subjects will receive the ZEST treatment protocol (Zocular Eyelid System treatment) to treat Meibomian Gland Dysfunction causing Contact Lens discomfort symptoms. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically determined presence of Meibomian gland dysfunction
- Patient Self-reported discomfort with contact lens wear
- Use of contact lenses on a daily basis
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zocular Eyelid System TreatmentAlso: ZESTZocular 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 | ZEST treatment |
Primary outcome
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.
2 secondary outcomes
MMP-9 expression
Time frame: One month
Tear break-up time
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 24145633Korb 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.
- Individual participant dataSharing planned: No. IPD will not be shared with other outside researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srihari Narayanan, OD, PhD principal investigator
University of the Incarnate Word
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zocular Eyelid System Treatment in people with Meibomian Gland Dysfunction and Dry Eye Syndromes, run by University of the Incarnate Word at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact Lens Questionnaire score (time frame: One month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.