Patients who schedule intraocular surgery
Conditions
Interventions
One drop of 1% SJP-0118 is instilled into the operative eye twice-daily (in the morning and in the evening) in the preoperative 3 days and once prior to the surgery on the day of surgery (Day 4).
Sponsors
Senju Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent obtained after adequate explanation on participating the study 2) Japanese male or female, 20 years of age or older at the time of obtaining consent, irrespective of inpatient or outpatient 3) Scheduled intraocular surgery
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative disinfection: the rate of patients who administered the study drug with a negative result in the bacteriological examination on the day of surgery or at the discontinuation | — |
Countries
Japan
Contacts
Public ContactYoshikuni Nakamura
Senju Pharmaceutical Co.,Ltd. Planning & Medical Writing, Clinical Development
Outcome results
None listed