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

Open-angle Glaucoma, Ocular Hypertension Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822559
• Other study ID #: 0111A04LT
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2019
• Est. completion date: April 4, 2023

Study information

• Verified date: July 2023
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma, Ocular Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital	Changsha
China	Eye & Ent Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the average diurnal IOP (intraocular pressure)	Diurnal IOP measurements will be performed at 8:00 (±1 h), 10:00 (±1 h) and 16:00 (±1 h).	Three months