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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822559
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma, Ocular Hypertension 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 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: DE-111A eye drops 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.
Active Comparator: 0.0015% tafluprost eye drops 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.


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822559


Contacts
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Contact: Santen Pharmaceutical Co., Ltd. +81-6-4802-9338 clinical@santen.co.jp

Locations
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China
Aier Eye Hospital Group Co., Ltd Changsha Aier Eye Hospital Recruiting
Changsha, China
Contact       clinical@santen.co.jp   
Eye & Ent Hospital of Fudan University Recruiting
Shanghai, China
Contact       clinical@santen.co.jp   
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03822559    
Other Study ID Numbers: 0111A04LT
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santen Pharmaceutical Co., Ltd.:
Glaucoma
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Pharmaceutical Solutions
 Ophthalmic Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents