NCT03822559

A Study of DE-111A on the Treatment of Open Angle Glaucoma or Ocular Hypertension

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open-angle Glaucoma, Ocular Hypertension

Interventions

Type	Name	Description
DRUG	A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL	One drop a time, once daily administration of DE-111A eye drops in the affected eye(s) at 8:00 am (±1h) for 3 months.
DRUG	A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL	One drop a time, once daily administration of preservative-free 0.0015% tafluprost eye drops in the affected eye(s) at 8:00 (±1h) for 3 months.

Timeline

• Start date: 2019-01-20
• Primary completion: 2023-04-04
• Completion: 2023-04-04
• First posted: 2019-01-30
• Last updated: 2023-07-14

Locations

2 sites across 1 country: China