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

NCT03822559 | Completed Phase 3

• 1 other identifier: 0111A04LT
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 2

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.

Conditions

Open-angle Glaucoma, Ocular Hypertension

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DE-111A eye drops

EXPERIMENTAL

Drug: 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

ACTIVE COMPARATOR

Drug: A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL

Interventions

A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL DRUG

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.

DE-111A eye drops

A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL DRUG

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.

0.0015% tafluprost eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital

Changsha, China

Location

Eye & Ent Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

tafluprost; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: January 30, 2019
• Study Start: January 20, 2019
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)