Bacterial conjunctivitis
Conditions
Interventions
SJP-0118 is instilled by twice on the first two days (once in the morning and at bedtime) and once a day in the morning for the following 5 days.
Vehicle is instilled by twice on the first two days (o
Sponsors
Senju Pharmaceutical co.,ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signature of the subject or legally authorized representative on the Informed Consent Form. 2) Male or female subject who is at least 19 year of age. 3) Subjects must have had a clinical diagnosis of bacterial conjunctivitis and exhibit conjunctival discharge and redness with minimum score of 1.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical resolution will be assessed at day 3 and 7 according to Guidelines for the Clinical Trials of Antibacterial Ophthalmic Solution [Nippon Ganka Gakkai Zasshi. 2015;119(4)273-86]. | — |
Countries
Japan
Contacts
Public ContactYoshikuni nakamura
Senju Pharmaceutical co.,ltd. Regulatory Affairs & Medical Writing, Clinical Development
Outcome results
None listed