Phase III study of Efficacy and Safety of SJP-0118 in bacterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion.

Not Applicable

• Conditions: acterial blepharitis, dacryocystitis or hordeolum/ acute suppurative chalazion

• Registration Number: JPRN-UMIN000019698
• Lead Sponsor: Senju Pharmaceutical co.,ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

1) Subjects with suspected fungal, viral, or Acanthamoeba infection. 2) Subjects with suspected allergic conjunctivitis. 3) History of recurrent corneal erosion syndrome. 4) Any corneal epithelial loss, specifically any corneal ulcer (except for superficial punctate keratitis). 5) Subject with best-corrected visual acuity equal to or less than 0.2 in both eyes. 6) Subject need to use concomitant therapy during the study. 7) Use of any antibiotic (systemic, topical or dermally around eyelid) within 1 week of enrollment. 8) Use of any corticosteroid or nonsteroidal antiinflammatory drug (systemic of topical). 9) Ocular surgery within the past 90 days. 10) Any cancer, clinically significant hepatic, renal, cardiovascular or endocrine system disorders. 11) Known hypersensitivity or adverse effect to azithromycin, any macrolide antibiotic, or to any of the ingredients in the study medications. 12) Willing to use contact lens or punctual plug during the study. 13) Pregnant, nursing, possibility of pregnancy or hope for the pregnancy during the study. 14) Participation in any other clinical study. 15) History of use azithromycin eye drops.

Study & Design

• Study Type: Interventional
• Study Design: Not specified