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Trial Detail

CUHK_CCT00463

2015-07-06

Prospective

KC/KE-15-0070/FR-2

Hong Kong Medical Supplies Ltd (Thea Laboratories)

Hong Kong Medical Supplies Ltd (Thea Laboratories)

N/A

Miss Mak Hoi Ching Haley

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Kowloon, Hong Kong

39435833

haleymak@cuhk.edu.hk

Department of Ophthalmology and Visual Sciences, Chinese University of Hong Kong

Dr. Vanissa Wing-see CHOW

3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

39435833

vanissa.chow@gmail.com

Department of Ophthalmology, Hong Kong Eye Hospital

Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

Azithromycin and Doxycycline in the Management of Meibomian Gland Dysfunction

阿奇黴素 (Azithromycin) 和多西環素 (Doxycycline) 治療瞼板腺功能失調 (Meibomian gland dysfunction)

MGD

Hong Kong

Yes

2015-06-10

Azithromycin, doxycyline, MGD, blepharitis, dry eyes

Drug

Azithromycin 1.5% Topical; Doxycyline 100mg Oral; Multivitamin Daily 1 Plus 1 tablet Oral

Three months

- 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
- Group 2 (study treatment): topical azithromycin as above, and oral doxycycline 100mg (1 tablet) a day concurrently for 28 days.

- Symptomatic meibomian gland dysfunction not responding to warm compresses, lid massage, and lubricants
- Older than 12 year old
- Able to give informed consent
- Able to comply with treatment and follow-up schedule

- On treatment for MGD or dry eye syndrome other than warm compresses, lid massage and lubricants in the past 3 months
- Schirmer’s test without anaesthesia <5mm per 5 minutes in both eyes
- Pretreatment LipiView score ≥ 100 in both eyes
- Known allergy to tetracycline or macrolide
- Pregnant or breast feeding women
- Women planning pregnancy
- Hepatic impairment or on hepatotoxic drugs
- Severe renal impairment
- Ocular condition that causes similar symptoms and signs as MGD, including structural lid abnormalities, lagothalmos, conjunctivochalasis, contact lens wear, thyroid eye disease
- On systemic medications that may contribute to dry eye without being on a stable dose in the past 1 month

12

999

Both Male and Female

Interventional

Randomized

Active

Double-blind

Parallel

2015-07-18

50

Not Yet Recruiting

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

- 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

No

2016-04-05

ChiCTR-IPC-15006715 

2015-07-09

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