A phase III open clinical study of SJP-0118 in patients who schedule intraocular surgery
- Conditions
- Patients who schedule intraocular surgery
- Registration Number
- JPRN-UMIN000026494
- 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
- 150
Not provided
1) Scheduled ocular surgery in the opposite eye to the treated eye during the study period 2) Possible ocular infection in the treated eye judged by clinical findings 3) Any history of recurrent erosion of cornea, particularly corneal ulcer, in the treated eye 4) Corneal findings of "+" or worse in the treated eye 5) Use of any antibiotic or synthetic antibacterial agent one week prior to the start of treatment (systemic, ocular instillation in either eye or topical dermal application around eyes) 6) Any history of ocular surgery in the treated eye within 90 days prior to the start of study treatment 7) 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 8) Known history of allergy or significant adverse drug reaction to any ingredients of the drugs used in this study (e.g. fluorescein, and so on), azithromycin or other macrolide antibiotics 9) 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