Clinical trial

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)

Name

0111A04LT

Description

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.

Trial arms

Trial start

2019-01-20

Estimated PCD

2023-04-04

Trial end

2023-04-04

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

DE-111A eye drops

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.

Arms:

0.0015% tafluprost eye drops

Size

219

Primary endpoint

Change from baseline in the average diurnal IOP (intraocular pressure)

Three months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 219, 'type': 'ACTUAL'}}

Updated at

2023-07-14

1 organization

2 products

2 indications

Organization

Santen Pharmaceutical

Product

Indication

Indication

Product