CLINICAL TRIAL

Treatment for Meibomian Gland Dysfunction

Grade II
Recruiting · 18+ · All Sexes · San Francisco, CA

This study is evaluating whether a common antibiotic may help improve symptoms of dry eye syndrome.

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About the trial for Meibomian Gland Dysfunction

Eligible Conditions
Depression, Anxiety · Eye Pain · Ocular Microbiome · Dry Eyes · Meibomian Gland Dysfunction · Neuropathic Eye Pain

Treatment Groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Control Group 1
Azithromycin Oral Product
DRUG
Control Group 2
Placebo Oral
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Symptomatic Meibomian gland disease, defined as patient-reported ocular surface symptoms such as dryness, grittiness, foreign body sensation, or eye fatigue in combination with clinically identifiable Meibomian gland disease with Grade 2 or greater involvement on the Meibomian Gland Grading Scale (Section XV, item 2).
OSDI Score greater than or equal to 20
Ability to give informed consent
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 3 months.
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 3 months.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 3 months..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 4 secondary outcomes in patients with Meibomian Gland Dysfunction. Measurement will happen over the course of Baseline to 3 months..

Personal Health Questionnaire (PHQ-9)
BASELINE TO 3 MONTHS.
Personal Health Questionnaire - a brief anxiety and depression questionnaire. Will be used in this study to evaluate the interaction between depression/anxiety and response to treatment.
BASELINE TO 3 MONTHS.
Dry Eye Questionnaire 5 (DE-5)
BASELINE TO 3 MONTHS.
Dry eye questionnaire 5 - used to evaluate the degree of dry eye symptoms. Scores range from 0-22. A score of 0 represents the minimum dry eye symptoms someone may have and a score of 22 represents the maximum dry eye symptoms someone may have.
BASELINE TO 3 MONTHS.
Ocular Surface Disease Index (OSDI) Questionnaire
BASELINE TO 3 MONTHS.
Ocular surface disease index - used to evaluate the degree of dry eye symptoms. Scores will range from 0 to 48, where 48 indicates severe dry eye.
BASELINE TO 3 MONTHS.
Ocular surface microbiome testing
BASELINE TO 3 MONTHS.
To evaluate the composition of the ocular surface microbiome using Shannon's diversity index. The alpha diversity (local species pool) of the population will be analyzed and compared pre-and post-treatment within and between the azithromycin and control groups. The difference between the bacterial microbiome in the azithromycin and placebo arm will be assessed using a PERMANOVA with an L2 norm distance measure. Secondary analyses will include L1 and L0 norms, as well as a phylogenetic distance. In addition, we will assess whether bacterial alpha diversity is decreased in the antibiotic treated arm with the primary outcome being the Simpson's index (L2), with secondary analyses assessing Shannon's (L1) and Richness (L0).
BASELINE TO 3 MONTHS.
Neuropathic Pain Inventory for the Eye (NPSI-E)
BASELINE TO 3 MONTHS.
Neuropathic pain inventory for the eye - used to study neuropathic vs stimulatory eye pain.
BASELINE TO 3 MONTHS.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is meibomian gland dysfunction?

Maintaining integrity of the meibomian gland is critical to preserve the function of the gland. If this integrity is impaired by smoking, the symptoms may be increased in the eyes. The condition is not only a cosmetic problem but also a health concern. It is not caused by a viral infection such as herpes simplex nor from a genetic predisposition to a disorder. It can be a health problem which increases the risks associated with smoking. Smoking causes irritation to the eyes (dry eyes syndrome), itchiness and irritation (hay fever), increased tearing and discharge (globus gland) and nasal congestion and sinus and ear congestion (this can be due to sinusitis).

Anonymous Patient Answer

What are the signs of meibomian gland dysfunction?

There is a high prevalence of meibomian gland dysfunction in the middle-aged and aging population. In patients aged ≥45 years, the condition becomes more prevalent in both genders. In patients aged ≥65 years, the condition is more prevalent in males. The prevalence of meibomian gland dysfunction is found to be the highest among patients of Chinese and Indian descent.

Anonymous Patient Answer

What causes meibomian gland dysfunction?

Meibomian gland dysfunction is a common cause of tear-related disorders. The main factor affecting the disorder appears to be meibomian glands, since their dysfunction is a leading cause of Sjögren syndrome.

Anonymous Patient Answer

Can meibomian gland dysfunction be cured?

[Occasionally, treatment of meibomian gland dysfunction may prove ineffective in some people and cause adverse side effects] (http://www.health-pages.com.au/whats-in-a-meibomian-gland-disorder/.). Therefore, the ultimate question is when do we agree to "misfire" and start a new regimen. One approach involves testing both the meibum, the lipid content of the meibomian Glands' secretions.

Anonymous Patient Answer

How many people get meibomian gland dysfunction a year in the United States?

[About one in three women between the ages of 20 and 58 have MGD and about 15 years ago the prevalence of the disease was about 5-10% in these younger women but by 2004 this prevalence was significantly increasing to [30% in 2005 and] 50% in 2008.[To find MGD clinical trials use www.withpower.com/clinical-trials]] to search by condition, treatment, or location.

Anonymous Patient Answer

What are common treatments for meibomian gland dysfunction?

In most cases, treatments include either medical therapies or procedures. One medical treatment may help control symptoms, such as meibomian gland function, that are associated with eyelid abnormalities.\n

Anonymous Patient Answer

What are the common side effects of treatment?

There is extensive data regarding treatment strategies to prevent, diagnose, and treat ODD. However, the most common side effects are not described, and therefore it is essential to know what side effects commonly occur during treatment in order to manage them and prevent their occurrence.

Anonymous Patient Answer

Is treatment typically used in combination with any other treatments?

Although no treatment has shown cure, many effective patients have good quality of life and good response to treatments and steroids. However, no one has an effect comparable to the other treatments. The best choice of treatment for a particular patient with Sjögren syndrome, which depends on the particular patient, has to be determined by a doctor in a consultation before starting treatment to be tailored by the patient as well as the general practitioner or ophthalmologist. Every patient's profile and previous successful treatments are taken into account when designing a treatment strategy.

Anonymous Patient Answer

Is treatment safe for people?

The most common side effects to treatment in those prescribed the product, of the four available drops, included dry eye, itching, and irritation. The majority of side effects were minor and usually resolved by 15 days. In no case did side effects cause discontinuation of treatment. The treatment of blepharitis appears to be safe for people prescribed the product and who have blepharitis symptoms and is well tolerated. Overall, this is a short-term treatment where the patient has to keep taking the treatment in the way described in the instructions. For more severe cases, or the patient who has failed two treatments, then contact [CVS] for a longer term treatment option.

Anonymous Patient Answer

Does treatment improve quality of life for those with meibomian gland dysfunction?

Patients with keratosis pilaris and meibomian gland dysfunction had a negative self-perceived quality of life and a depressed perceived quality of life. Self-reported quality of life was improved the most significantly for those who had undergone the treatment.

Anonymous Patient Answer

What is the average age someone gets meibomian gland dysfunction?

When patients are treated with the same surgical and non-surgical methods, the median age of symptoms presentation was 37 years (range: 17-82). Patients who present with symptoms after 42 years of age (95th centile) typically have the disorder related to a family history or have had a surgical procedure that has damaged the tear sac. There was no significant differences in the mean age of symptom onset, symptom severity, or age at intervention by gender or surgical approach - a significant improvement in surgical outcomes. Recent findings of this study suggest that people who present with symptoms ≤42 years have a similar likelihood of having MGD related to a family history or prior surgical intervention for other ocular problems.

Anonymous Patient Answer

What is treatment?

In this review, both medications and meibomian gland surgery have yielded satisfactory relief of meibomian gland dysfunction. Many patients require more than 1 treatment modality. Although the efficacy of meibomian gland surgery is unknown at this time, it may be the future. Nevertheless, the advantages of each individual therapy should be reviewed thoroughly and weighed against its costs and risks.

Anonymous Patient Answer
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