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

Phase 3

Completed

• Conditions: Open-angle Glaucoma, Ocular Hypertension
• Interventions: Drug: A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL; Drug: A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL

• Registration Number: NCT03822559
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-20
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-111A eye drops	A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL	-
0.0015% tafluprost eye drops	A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the average diurnal IOP (intraocular pressure)	Three months	Diurnal IOP measurements will be performed at 8:00 (±1 h), 10:00 (±1 h) and 16:00 (±1 h).

Trial Locations

Locations (2)

Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital; 🇨🇳 Changsha, China

Eye & Ent Hospital of Fudan University; 🇨🇳 Shanghai, China