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Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-15006715
Enrollment
Unknown
Registered
2015-07-09
Start date
2015-07-18
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Azithromycin, doxycyline, MGD, blepharitis, dry eyes

Interventions

Two groups:Azithromycin 1.5% Topical
Doxycyline 100mg Oral
Multivitamin Daily 1 Plus 1 tablet Oral Three months
(to be continued):Group 1 (control treatment): topical azithromycin to both eyes, twice daily for 3 days, then once daily for 25 days
and oral multivitamin (Daily 1 Plus) 1 tablet a day concurrently for 28 days as placebo
(to be continured):Group 2 (study treatment): topical azithromycin as above, and oral doxycycline 100mg (1 tablet) a day concurrently for 28 days.

Sponsors

Hong Kong Medical Supplies Ltd (Thea Laboratories)
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
12 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Symptomatic meibomian gland dysfunction not responding to warm compresses, lid massage, and lubricants; 2. Older than 12 year old; 3. Able to give informed consent; 4. Able to comply with treatment and follow-up schedule.

Exclusion criteria

Exclusion criteria: 1. On treatment for MGD or dry eye syndrome other than warm compresses, lid massage and lubricants in the past 3 months; 2. Schirmer's test without anaesthesia =100 in both eyes; 3. Known allergy to tetracycline or macrolide; 4. Pregnant or breast feeding women; 5. Women planning pregnancy; 6. Hepatic impairment or on hepatotoxic drugs; 7. Severe renal impairment; 8. Ocular condition that causes similar symptoms and signs as MGD, including structural lid abnormalities, lagothalmos, conjunctivochalasis, contact lens wear, thyroid eye disease; 9. On systemic medications that may contribute to dry eye without being on a stable dose in the past 1 month.

Design outcomes

Primary

MeasureTime frame
Improvement in symptom frequency score based on self-administered OSDI questionnaire at month 1;

Secondary

MeasureTime frame
Improvement in symptom frequency score based on self-administered OSDI questionnaire at month 3;Improvement in symptom severity score based on self-administered SPEED questionnaire;Clinical grading of MGD based on conjunctival injection, lid margin redness, ocular surface staining, meibomian gland expressability, number of glands plugged and quality of meibum13;Best- corrected visual acuity;Lipid layer thickness measurement by LipiView interferometer (TearScience Inc., Morrisville, NC, USA) The LipiView interferometer (TearScience Inc., Morrisville, NC, USA) measures interferometric color units (ICU), where 1 ICU approximately reflects 1 nm of the lipid layer thickness.;18 A LipiView image of the tear film can be captured during a non-invasive in-office exam that takes about 5 minutes.;The tear film can be seen as an array of colors called specular observations that are relected when the subject rest his head on the chin-rest and a controlled light source is directed towards the front surface of the eye.;Non-invasive tear break-up time, infrared meibography, tear film assessment and R-scan (bulbar conjunctival redness evaluation) with OCULUS Keratograph 5M (Oculus, Wetzlar, Germany) OCULUS Keratograph 5M (Oculus, Wetzlar, Germany) uses white or infrared illumination to assess the tear film and tear break-up time;infrared camera for meibomian gland imaging; and color camera for conjunctival blood vessel imaging.;All measurements will be non-invasive. Subjects will be instructed to rest his head on the chin- rest during imaging, which takes about 5 minutes.;Tear analysis (10 patients in each arm): osmolarity, cytokines, matrix metalloproteinases;Side effects noted during treatment;Compliance to treatment;

Countries

China

Contacts

Public ContactDr. Vanissa Wing-see CHOW
vanissa.chow@gmail.com+852 39435833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026