Topical Azithromycin Improves Blepharitis Signs and Symptoms W.B. Trattler c , K.L. Kuhn e , R. Haque e , R.C. Zink e , K.N. Sall c and J.I. Luchs c Disclosure: Authors are: c – Consultants; e – Employees of Inspire Pharmaceuticals, Inc. Study Details . Pilot study*, open-label
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Topical Azithromycin Improves Blepharitis Signs and SymptomsW.B. Trattlerc, K.L. Kuhne, R. Haquee, R.C. Zinke,K.N. Sallc and J.I. LuchscDisclosure:Authors are: c – Consultants; e – Employees of Inspire Pharmaceuticals, Inc.
*This study pertains to an off-label use of AzaSite®
Age ≥ 18 years
Clinical diagnosis of moderate to severe chronic blepharitis
Clinical sign/symptom severity score of at least moderate (2) severity on either eyelid margin hyperemia or eyelid swelling, or both.
Clinical sign severity score of at least moderate (2) severity on either eyelid debris or plugging of the meibomian glands, or both.
Have a symptom severity score of at least moderate (2) on their self-reported “most bothersome” symptom at baseline and a score of at least moderate (2) on any other symptom
Best corrected visual acuity of at least +0.7 as assessed by ETDRS
Use of eyelid scrubs within 2 weeks of Visit 1 and for the duration of the study
Use of mechanical therapy (warm compresses) within 2 weeks of Visit 1
Unwilling to discontinue contact lens wear for the duration of the study
History of ocular surface surgical intervention within 12 months prior to the study
Use of any preserved topical ophthalmic medications at entry or during the study
Use of topical ocular or orally administered antibiotics within 30 days of Visit 1 and for the duration of the study
Use of topical cyclosporine within 30 days of Visit 1 and for the duration of the study
Use of topical ocular steroids or NSAIDS 2 weeks prior to entry or during the studyInclusion/Exclusion Criteria
Azithromycin Ophthalmic Solution, 1% + Warm Compresses
Warm Compresses Alone
Day 1 Day 8±2 Day 15±2 Day 22±2 Day 29±2 Day 43±2
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6Study Design
*scales for individual signs/symptoms range from 0= normal/none to 4=very severe/obstructed
(2 wks off tx)
*summation of five individual symptoms (foreign body sensation, ocular itching, ocular dryness, burning/painful eyes, swollen/heavy eyelids); 0-20 range
(2 wks off tx)
*summation of individual signs (eyelid debris, eyelid swelling, plugging of the meibomian gland, meibomian gland secretions and eyelid margin hyperemia); 0-20 range