Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Clinical Phase
PHASE4
Total Enrollment
2 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-09-01
Study Completion Date
2021-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study aims to elucidate the effectiveness of oral azithromycin in treating symptomatic dry eye syndrome secondary to Meibomian gland dysfunction.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
NCT01014078
Dry Eye Disease
COMPLETED
PHASE4
Comparing Efficacy of Tea Tree Oil Versus Topical Azithromycin in Treating Dry Eye
NCT06921525
Dry Eye
NOT_YET_RECRUITING
PHASE1/PHASE2
Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction
NCT03162497
Dry Eye Syndromes
Meibomian Gland Dysfunction
COMPLETED
PHASE4
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Four-Week Treatment Period (P08638)
NCT00894530
Blepharitis
COMPLETED
PHASE2
Safety and Efficacy Pilot Study of AzaSite (Azithromycin) in Subjects With Blepharitis
NCT00629590
Blepharitis
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Dry Eye
Neuropathic Eye Pain
Ocular Microbiome
Depression, Anxiety
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo Oral
Intervention Type
DRUG
Oral placebo tablet
Azithromycin
Group Type
ACTIVE_COMPARATOR
Azithromycin Oral Product
Intervention Type
DRUG
Oral azithromycin dosed at 1 gram per week for 3 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azithromycin Oral Product
Oral azithromycin dosed at 1 gram per week for 3 weeks
Intervention Type
DRUG
Placebo Oral
Oral placebo tablet
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Zithromax
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Francisco
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julie Schallhorn, MD, MS
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Thuy Doan, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California San Francisco
San Francisco, California, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
Pflugfelder SC. Prevalence, burden, and pharmacoeconomics of dry eye disease. Am J Manag Care. 2008 Apr;14(3 Suppl):S102-6.
Reference Type
BACKGROUND
The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):93-107. doi: 10.1016/s1542-0124(12)70082-4.
Reference Type
BACKGROUND
Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1994-2005. doi: 10.1167/iovs.10-6997e. Print 2011 Mar. No abstract available.
Reference Type
BACKGROUND
Foulks GN, Bron AJ. Meibomian gland dysfunction: a clinical scheme for description, diagnosis, classification, and grading. Ocul Surf. 2003 Jul;1(3):107-26. doi: 10.1016/s1542-0124(12)70139-8.
Reference Type
BACKGROUND
Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.
Reference Type
BACKGROUND
King-Smith PE, Bailey MD, Braun RJ. Four characteristics and a model of an effective tear film lipid layer (TFLL). Ocul Surf. 2013 Oct;11(4):236-45. doi: 10.1016/j.jtos.2013.05.003. Epub 2013 Jul 12.
Reference Type
BACKGROUND
Lane SS, DuBiner HB, Epstein RJ, Ernest PH, Greiner JV, Hardten DR, Holland EJ, Lemp MA, McDonald JE 2nd, Silbert DI, Blackie CA, Stevens CA, Bedi R. A new system, the LipiFlow, for the treatment of meibomian gland dysfunction. Cornea. 2012 Apr;31(4):396-404. doi: 10.1097/ICO.0b013e318239aaea.
Reference Type
BACKGROUND
Lee H, Chung B, Kim KS, Seo KY, Choi BJ, Kim TI. Effects of topical loteprednol etabonate on tear cytokines and clinical outcomes in moderate and severe meibomian gland dysfunction: randomized clinical trial. Am J Ophthalmol. 2014 Dec;158(6):1172-1183.e1. doi: 10.1016/j.ajo.2014.08.015. Epub 2014 Aug 13.
Reference Type
BACKGROUND
Prabhasawat P, Tesavibul N, Mahawong W. A randomized double-masked study of 0.05% cyclosporine ophthalmic emulsion in the treatment of meibomian gland dysfunction. Cornea. 2012 Dec;31(12):1386-93. doi: 10.1097/ICO.0b013e31823cc098.
Reference Type
BACKGROUND
Macsai MS. The role of omega-3 dietary supplementation in blepharitis and meibomian gland dysfunction (an AOS thesis). Trans Am Ophthalmol Soc. 2008;106:336-56.
Reference Type
BACKGROUND
Deinema LA, Vingrys AJ, Wong CY, Jackson DC, Chinnery HR, Downie LE. A Randomized, Double-Masked, Placebo-Controlled Clinical Trial of Two Forms of Omega-3 Supplements for Treating Dry Eye Disease. Ophthalmology. 2017 Jan;124(1):43-52. doi: 10.1016/j.ophtha.2016.09.023. Epub 2016 Nov 3.
Reference Type
BACKGROUND
Hosseini K, Lindstrom RL, Foulks G, Nichols KK. A randomized, double-masked, parallel-group, comparative study to evaluate the clinical efficacy and safety of 1% azithromycin-0.1% dexamethasone combination compared to 1% azithromycin alone, 0.1% dexamethasone alone, and vehicle in the treatment of subjects with blepharitis. Clin Ophthalmol. 2016 Aug 10;10:1495-503. doi: 10.2147/OPTH.S110739. eCollection 2016.
Reference Type
BACKGROUND
Greene JB, Jeng BH, Fintelmann RE, Margolis TP. Oral azithromycin for the treatment of meibomitis. JAMA Ophthalmol. 2014 Jan;132(1):121-2. doi: 10.1001/jamaophthalmol.2013.5295. No abstract available.
Reference Type
BACKGROUND
Yoo SE, Lee DC, Chang MH. The effect of low-dose doxycycline therapy in chronic meibomian gland dysfunction. Korean J Ophthalmol. 2005 Dec;19(4):258-63. doi: 10.3341/kjo.2005.19.4.258.
Reference Type
BACKGROUND
Ta CN, Shine WE, McCulley JP, Pandya A, Trattler W, Norbury JW. Effects of minocycline on the ocular flora of patients with acne rosacea or seborrheic blepharitis. Cornea. 2003 Aug;22(6):545-8. doi: 10.1097/00003226-200308000-00011.
Reference Type
BACKGROUND
Wladis EJ, Bradley EA, Bilyk JR, Yen MT, Mawn LA. Oral Antibiotics for Meibomian Gland-Related Ocular Surface Disease: A Report by the American Academy of Ophthalmology. Ophthalmology. 2016 Mar;123(3):492-6. doi: 10.1016/j.ophtha.2015.10.062. Epub 2015 Dec 23.
Reference Type
BACKGROUND
Watters GA, Turnbull PR, Swift S, Petty A, Craig JP. Ocular surface microbiome in meibomian gland dysfunction. Clin Exp Ophthalmol. 2017 Mar;45(2):105-111. doi: 10.1111/ceo.12810. Epub 2016 Sep 7.
Reference Type
BACKGROUND
Giamarellos-Bourboulis EJ. Macrolides beyond the conventional antimicrobials: a class of potent immunomodulators. Int J Antimicrob Agents. 2008 Jan;31(1):12-20. doi: 10.1016/j.ijantimicag.2007.08.001. Epub 2007 Nov 1.
Reference Type
BACKGROUND
Liu Y, Ding J. The combined effect of azithromycin and insulin-like growth factor-1 on cultured human meibomian gland epithelial cells. Invest Ophthalmol Vis Sci. 2014 Aug 14;55(9):5596-601. doi: 10.1167/iovs.14-14782.
Reference Type
BACKGROUND
Liu Y, Kam WR, Ding J, Sullivan DA. Effect of azithromycin on lipid accumulation in immortalized human meibomian gland epithelial cells. JAMA Ophthalmol. 2014 Feb;132(2):226-8. doi: 10.1001/jamaophthalmol.2013.6030. No abstract available.
Reference Type
BACKGROUND
Igami TZ, Holzchuh R, Osaki TH, Santo RM, Kara-Jose N, Hida RY. Oral azithromycin for treatment of posterior blepharitis. Cornea. 2011 Oct;30(10):1145-9. doi: 10.1097/ICO.0b013e318207fc42.
Reference Type
BACKGROUND
Haque RM, Torkildsen GL, Brubaker K, Zink RC, Kowalski RP, Mah FS, Pflugfelder SC. Multicenter open-label study evaluating the efficacy of azithromycin ophthalmic solution 1% on the signs and symptoms of subjects with blepharitis. Cornea. 2010 Aug;29(8):871-7. doi: 10.1097/ICO.0b013e3181ca38a0.
Reference Type
BACKGROUND
Luchs J. Azithromycin in DuraSite for the treatment of blepharitis. Clin Ophthalmol. 2010 Jul 30;4:681-8. doi: 10.2147/opth.s6370.
Reference Type
BACKGROUND
Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
Reference Type
BACKGROUND
Korb DR, Blackie CA. Meibomian gland diagnostic expressibility: correlation with dry eye symptoms and gland location. Cornea. 2008 Dec;27(10):1142-7. doi: 10.1097/ICO.0b013e3181814cff.
Reference Type
BACKGROUND
Meadows JF, Ramamoorthy P, Nichols JJ, Nichols KK. Development of the 4-3-2-1 meibum expressibility scale. Eye Contact Lens. 2012 Mar;38(2):86-92. doi: 10.1097/ICL.0b013e318242b494.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
17-23877
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis
NCT00629980
COMPLETED
PHASE4
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Vehicle in Subjects With Blepharitis (P08636)
NCT01269658
TERMINATED
PHASE2
The Effects of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Blepharitis During a Two-Week Treatment Period
NCT00892970
COMPLETED
PHASE2
Safety and Efficacy Study of AzaSite® in Subjects With Blepharitis
NCT00629941
COMPLETED
PHASE4
Study to Determine the Effect of Azasite on Corneal Surface Irregularity
NCT01797107
WITHDRAWN
PHASE2
Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia
NCT00347776
COMPLETED
PHASE4
A Four Week, Open-Label Study of Azithromycin Ophthalmic Solution, 1% (P08641)
NCT01220258
TERMINATED
PHASE2
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
NCT01105624
COMPLETED
PHASE4
Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis
NCT00656539
COMPLETED
PHASE4
A Multicenter Study Evaluating AZR-MD-001 in Patients With Meibomian Gland Dysfunction and Evaporative Dry Eye Disease (DED)
NCT03652051
COMPLETED
PHASE2
The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
NCT01178762
COMPLETED
NA
A Phase 3 Study to Evaluate AZR-MD-001 in Patients with Abnormal Meibomian Gland Function and Dry Eye Disease (DED)
NCT06329791
ACTIVE_NOT_RECRUITING
PHASE3
Lipids of the Human Tear Film and Their Effect on Tear Stability
NCT00803452
COMPLETED
PHASE4
Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
NCT00356772
COMPLETED
PHASE1
A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults
NCT05969236
COMPLETED
PHASE1
Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction
NCT04884243
COMPLETED
PHASE2
Study to Evaluate the Safety and Efficacy of Minocycline Ointment in Subjects With Inflamed Meibomian Gland Dysfunction
NCT03888378
COMPLETED
PHASE2
Effects of Minocycline on Cytokine Levels in Severe Meibomian Gland Dysfunction
NCT01600625
COMPLETED
NA
Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction
NCT05261386
COMPLETED
PHASE2
Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers
NCT03235141
UNKNOWN
PHASE1
Topical Steroid Treatment For Dry Eye
NCT02218827
UNKNOWN
NA
Evaluation of AZR-MD-001 in Patients With Meibomian Gland Dysfunction (MGD)
NCT04391959
COMPLETED
PHASE2
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
NCT00105469
COMPLETED
PHASE3
Partnership for Rapid Elimination of Trachoma
NCT00792922
COMPLETED
PHASE4
A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
NCT06309953
COMPLETED
PHASE4