Status:
COMPLETED
A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Conditions:
Open-angle Glaucoma, Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to investigate whether the IOP (intraocular pressure) -lowering effect of DE-111A (preservative-free fixed dose combination of 0.0015% tafluprost and 0.5% timolol eye dr...
Eligibility Criteria
Inclusion
- Diagnosis of open angle glaucoma (including primary open angle glaucoma, exfoliation glaucoma or pigmentary glaucoma) in one or both eyes or ocular hypertension for which the subject has been using prostaglandin or beta-adrenergic blocker IOP (intraocular pressure) -lowering drugs before the screening visit
- Those who have signed the informed consent form
Exclusion
- Women who are pregnant, nursing or planning pregnancy, or women of child-bearing potential who are not using a reliable method of contraception
- Anterior chamber angle in either eye to be treated with the level \<2 according to Shaffer classification as measured by gonioscopy
- Corneal disorder or other disease preventing reliable applanation tonometry in the treated eyes, including refractive surgery of ocular anterior segment)
- Alcohol or drug abuse
- Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within 30 days before Screening visit
Key Trial Info
Start Date :
January 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2023
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT03822559
Start Date
January 20 2019
End Date
April 4 2023
Last Update
July 14 2023
Active Locations (2)
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1
Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital
Changsha, China
2
Eye & Ent Hospital of Fudan University
Shanghai, China