Phase I study of SJP-0118 in healthy elderly (once a daily and twice a daily dosing study)
- Conditions
- Healthy Elderly
- Registration Number
- JPRN-UMIN000019877
- 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
- 45
Not provided
1) Abnormal findings with ocular biomicroscopy in either eye. 2) History of recurrent corneal erosion syndrome. 3) Any corneal abnormalities (except for physiological superficial punctate keratitis) in either eye. 4) Subject with best-corrected visual acuity equal to or less than 0.3 in either eye. 5) History of ocular injury within the past 90 days. 6) Willing to use contact lens or punctual plug during the study. 7) Ocular surgery within the past 90 days in either eye. 8) Subject need to use any drugs (including over the counter drugs) within past 1 week and during the study. 9) Any cancer, clinically significant hepatic, renal, cardiovascular or endocrine system disorders. 10) Known hypersensitivity or adverse effect to azithromycin, any macrolide antibiotic, or to any of the ingredients in the study medications. 11) Participation in any other clinical study within past 90 days. Willing to participate in other clinical study during the study. 12) History of use azithromycin eye drops.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method