Healthy Elderly
Conditions
Interventions
SJP-0118 is instilled by once a day for 4 days.
SJP-0118 is instilled by twice on the first three days and once a day on the day 4.
Sponsors
Senju Pharmaceutical co.,ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signature of the subject on the Informed Consent Form. 2) Male or female subject who is at least 65year of age.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation (Clinical examination, Vital sign, Ophthalmic examination, Adverse event) will be assessed from day 1 to 4 and eradiation rates at day 4 | — |
Countries
Japan
Contacts
Public ContactYoshikuni Nakamura
Senju Pharmaceutical co.,ltd. Regulatory Affairs & Medical Writing, Clinical Development
Outcome results
None listed