Status:
COMPLETED
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
Lead Sponsor:
Santen Inc.
Conditions:
Primary Open-angle Glaucoma and Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double-masked, parallel-group, multi-center study. Subjects diagnosed with POAG or OHT who meet eligibility criteria at Visit 1 (Screening) will wash out their current topical IO...
Eligibility Criteria
Inclusion
- Provide signed written informed consent
- Have a diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
- Qualifying corrected visual acuity in each eye
- Qualifying central corneal thickness in each eye
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes
- Qualifying Anterior chamber angle
Exclusion
- History of ocular surgery specifically intended to lower IOP
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
- Advanced glaucoma in either eye
- Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
- Any ocular surgery or ocular laser treatment within 180 days prior to Screening and throughout the study in either eye
- Females who are pregnant, nursing, or planning a pregnancy
Key Trial Info
Start Date :
January 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03858894
Start Date
January 28 2019
End Date
June 20 2019
Last Update
August 4 2020
Active Locations (13)
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1
East West Eye Institute
Los Angeles, California, United States, 90013
2
Danbury Eye Specialist
Danbury, Connecticut, United States, 06810
3
Hernando Eye Institute
Brooksville, Florida, United States, 34613
4
Levenson Eye Associates
Jacksonville, Florida, United States, 32204