Study of ST266 Given by Intranasal Delivery in Glaucoma Suspect Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ocular Hypertension
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: This clinical trial is a dose escalating design in three (3) cohorts of three (3) subjects per Cohort. In the first cohort, subjects will be administered ST266, delivered intranasally, at a dose of two hundred microliters (200 µL) daily for 14 days, in alternating single nostrils. After 14 daily treatments there is a seven (7)-day follow-up period. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort of three (3) subjects. In Cohort Two, three (3) subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 14 days. There will be a seven (7)-day follow-up. Like Cohort One, if there are no safety concerns, the investigator may move on to the third cohort of three (3) subjects. In Cohort Three, three (3) subjects will be administered 200 µL to each nostril daily (400 µL total per day) for 28 days.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 75 years
- Gender
- Both males and females
Description
This clinical trial is a dose escalating design in three (3) cohorts. In the first cohort, subjects will be treated with ST266 delivered using a non-invasive trans-cribriform intranasal delivery device daily for 14 days, in alternating single nostrils. If there are no SAEs and no pattern of concern ...
This clinical trial is a dose escalating design in three (3) cohorts. In the first cohort, subjects will be treated with ST266 delivered using a non-invasive trans-cribriform intranasal delivery device daily for 14 days, in alternating single nostrils. If there are no SAEs and no pattern of concern in the AE's, the Investigator may proceed to the second cohort. In Cohort Two, subjects will be administered ST266 to each nostril daily for 14 days. As with the first cohort, if there are no safety concerns, the investigator may move on to the third cohort. In Cohort Three, subjects will be administered ST266 to each nostril daily for 28 days. All subjects will be followed for 12 months after the last dose of study drug. ST266 will be administered by a health care professional trained to deliver ST266 intranasally. No efficacy data will be collected.
Tracking Information
- NCT #
- NCT03901781
- Collaborators
- Not Provided
- Investigators
- Not Provided
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