clinical trial · NCT03822559
A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension
Santen Pharmaceutical Co., Ltd.·phase3·completed·n = 219
Open-angle Glaucoma, Ocular HypertensionA preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mLA preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL
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 drops, administered one drop a time, once daily for 3 months) is superior to the monotherapy of tafluprost 0.0015% eye drops administered one drop a time, once daily for 3 months) in subjects with open-angle glaucoma or ocular hypertension in China as well as comparison of safety.
started
Jan 20, 2019
primary completion
Apr 4, 2023
completion
Apr 4, 2023
last updated
Jul 14, 2023
official title
A Randomized, Double-masked, Controlled Parallel Group, Multi-center Study of DE-111A (Fixed Dose Combination of Tafluprost and Timolol Eye Drops) on the Treatment of Open Angle Glaucoma or Ocular Hypertension (With Tafluprost Eye Drops as a Comparator)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol