Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AKB-9778 Ophthalmic Solution
Lead Sponsor:
Aerpio Therapeutics
Conditions:
Ocular Hypertension
Primary Open Angle Glaucoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of AKB-9778 ophthalmic solution (eye drops) administered for 7 days in adults. The stu...
Eligibility Criteria
Inclusion
- Key
- Aged \> 18 years to 70 years inclusive in Cohort 1; aged ≥ 45 to 70 years inclusive in Cohorts 2-4, aged 18 to 80 years inclusive in Cohort 5.
- For subjects in Cohort 1, IOP between 12 and 23 mm Hg (inclusive). For subjects in Cohorts 2-4, IOP between 16 and 23mm Hg (inclusive). For subjects in Cohort 5, IOP between 17 and 27 mm Hg (inclusive).
- Central corneal thickness of 480 to 600 μm, inclusive
- For subjects in Cohort 5, diagnosis of OAG or OHT
- For subjects in Cohort 5, currently receiving prostaglandin therapy for IOP lowering
- Key
Exclusion
- Diagnosis of any form of glaucoma in Cohorts 1-4
- Clinically significant eye trauma within 6 months of screening
- Any intraocular ophthalmic procedure within 6 months of screening
- Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye
- Subjects with any known chronic ocular disease (other than incipient cataract or refractive error)
- Any condition preventing valid applanation tonometry measurement, e.g., clinically significant corneal disease, refractive surgery
- Visual acuity (VA) worse than 20/30 in either eye, For Cohort 5 VA worse than 20/100 in either eye
Key Trial Info
Start Date :
May 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2019
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT04284514
Start Date
May 2 2019
End Date
December 15 2019
Last Update
February 25 2020
Active Locations (2)
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1
PPD
Austin, Texas, United States, 78744
2
Covance Clinical Research Unit
Dallas, Texas, United States, 75247