A phase III placebo-controlled comparative study of SJP-0118 in patients with bacterial conjunctivitis
- Conditions
- bacterial conjunctivitis
- Registration Number
- JPRN-UMIN000027039
- Lead Sponsor
- Senju Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 640
Not provided
1) Possible ocular infection other than the trial indication 2) Possible allergic conjunctivitis or onset of its symptom during the study 3) Any history of recurrent erosion of cornea 4) Corneal findings of "+" or worse 5) Corrected visual acuity =<0.2 6) Instillation of any ophthalmic solution within 2 hours prior to the examinations on the start day of treatment 7) Systemic use, ocular instillation or topical dermal application around eyes of any antibiotic or synthetic antibacterial agent within one week prior to the start of treatment 8) Systemic use of corticosteroids or ocular instillation of corticosteroids or NSAIDs within one week prior to the start of treatment 9) Ocular surgery within 90 days prior to the start of treatment 10) Presence of a cancer or a serious systemic disease such as serious hepatic disorder, serious renal disorder, serious cardiovascular disease or serious endocrine system disease 11) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study, azithromycin or other macrolide antibiotics 12) Past ocular instillation of azithromycin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method