Azithromycin for Meibomian Gland Disease
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| ClinicalTrials.gov Identifier: NCT03953118 |
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Recruitment Status :
Recruiting
First Posted : May 16, 2019
Last Update Posted : February 3, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Dry Eye Neuropathic Eye Pain Ocular Microbiome Depression, Anxiety | Drug: Azithromycin Oral Product Drug: Placebo Oral | Phase 4 |
This is a randomized, placebo-controlled, double masked trial of the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction. Dry eye syndrome (DES) is a persistent feeling of ocular discomfort that encompasses dryness, irritation, foreign body sensation and burning. In the United States, it is the most common non-refractive cause of visits to eye care providers, and has been shown to have a significant impact on quality of life of patients who suffer from this condition. most common cause of DES is Meibomian gland disease (MGD). In the vast majority of cases, MGD is not binding, but rather causes persistant ocular discomfort.
Oral antibiotics, particularly the tetracyclines and macrolides, are frequently prescribed for the treatment of MGD. There is little good-quality evidence to support this practice. This study is designed to evaluate the effectiveness of oral azithromycin on patient-reported dry eye symptoms. Concomitantly, we will also study the composition of the ocular surface microbiome in MGD, and its response for oral antibiotics.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Care Provider) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Controlled Trial to Evaluate the Role of Oral Azithromycin in the Treatment of Symptomatic Meibomian Gland Disease and Its Effect on the Ocular Surface Microbiome |
| Actual Study Start Date : | September 1, 2018 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Drug: Placebo Oral
Oral placebo tablet |
| Active Comparator: Azithromycin |
Drug: Azithromycin Oral Product
Oral azithromycin dosed at 1 gram per week for 3 weeks
Other Name: Zithromax |
- Ocular Surface Disease Index (OSDI) Questionnaire [ Time Frame: Baseline to 1 month. ]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.
- Ocular Surface Disease Index (OSDI) Questionnaire [ Time Frame: 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.
- Ocular surface microbiome testing [ Time Frame: Baseline to 1 month. ]
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).
- Ocular surface microbiome testing [ Time Frame: 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).
- Dry Eye Questionnaire 5 (DE-5) [ Time Frame: Baseline to 1 month. ]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.
- Dry Eye Questionnaire 5 (DE-5) [ Time Frame: 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.
- Neuropathic Pain Inventory for the Eye (NPSI-E) [ Time Frame: Baseline to 1 month. ]Neuropathic pain inventory for the eye - used to study neuropathic vs stimulatory eye pain.
- Neuropathic Pain Inventory for the Eye (NPSI-E) [ Time Frame: Baseline to 3 months. ]Neuropathic pain inventory for the eye - used to study neuropathic vs stimulatory eye pain.
- Personal Health Questionnaire (PHQ-9) [ Time Frame: Baseline to 1 month. ]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.
- Personal Health Questionnaire (PHQ-9) [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age less than 18 years
- Allergy or intolerance to oral azithromycin or topical dexamethasone
- Allergy or intolerance to the preservatives used in topical ophthalmic 0.1% dexamethasone: sodium bisulfite, phenylethyl alcohol, benzalkonium chloride
- History of prolonged QT interval, history of torsades des pointes, congenital long QT syndrome, bradyarrhythmias, heart failure
- Patients currently taking medications that prolong the QT interval (Table 1)
- Aqueous deficiency dry eye defined as Schirmer's strip testing without anesthesia with £ 5mm of tears on two separate tests.
- Ocular surface inflammatory disease, including cicatrizing conjunctivitis, graft versus host disease, Stevens Johnson syndrome
- Atopic disease with ocular involvement
- Limbal stem cell deficiency
- Oral or topical ophthalmic antibiotic use within the last 90 days
- Oral prednisone use >5mg per day
- Topical ophthalmic steroid use within the past 30 days
- Topical ophthalmic anti-inflammatory (including non-steroidal anti-inflammatory medications, lifitegrast, or cyclosporine) use within the past 30 days
- Patients who are currently pregnant, planning on becoming pregnant during the study period, or currently breastfeeding.
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): NCT03953118
| Contact: Khashayar Nattagh, BA | 19499107667 | khash.nattagh@ucsf.edu | |
| Contact: Julie Schallhorn, MD, MS | julie.schallhorn@ucsf.edu |
| United States, California | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: khashayar nattagh 949-910-7667 knattagh@gmail.com | |
| Sub-Investigator: John A Gonzales, MD | |
| Sub-Investigator: Jennifer Rose-Nussbaumer, MD | |
| Sub-Investigator: Geremi Seitzman, MD | |
| Sub-Investigator: Neeti Parikh, MD | |
| Sub-Investigator: Matilda Chan, MD, PhD | |
| Sub-Investigator: Khashayar Nattagh, BA | |
| Principal Investigator: | Julie Schallhorn, MD, MS | University of California, San Francisco | |
| Principal Investigator: | Thuy Doan, MD, PhD | University of California, San Francisco |
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT03953118 |
| Other Study ID Numbers: |
17-23877 |
| First Posted: | May 16, 2019 Key Record Dates |
| Last Update Posted: | February 3, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Eye Pain Eye Manifestations Eye Diseases Pain |
Neurologic Manifestations Azithromycin Anti-Bacterial Agents Anti-Infective Agents |