Status:
COMPLETED
Multicenter Study Assessing the Efficacy and Safety of DE-126 Ophthalmic Solution 0.002% Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Santen Inc.
Conditions:
Primary Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Reduction of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the...
Eligibility Criteria
Inclusion
- Have been diagnosed of POAG or OHT in both eyes, or one eye with OAG and other with OHT
- Completed the required wait/washout period
- Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Exclusion
- Females who are pregnant, nursing, or planning a pregnancy
- Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period.
- History of ocular surgery specifically intended to lower IOP in either eye. Laser iridotomy in history is allowed
- Presence of advanced glaucoma in either eye
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT04742283
Start Date
December 17 2020
End Date
December 7 2021
Last Update
June 22 2023
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Eye Center
Chandler, Arizona, United States, 85224
2
Arizona Glaucoma Specialists
Phoenix, Arizona, United States, 85050
3
Walman Eye Center
Sun City, Arizona, United States, 85351-3019
4
Global Research Management
Glendale, California, United States, 91204-2569