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DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

DE-111 ophthalmic solution

Tafluprost ophthalmic solution 0.0015%

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Primary open angle glaucoma or ocular hypertension

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

Diagnosed with primary open angle glaucoma or ocular hypertension
Provided signed, written informed consent
20 years of age and older
If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
Presence of any abnormality or significant illness that could be expected to interfere with the study.

Sites / Locations

Santen study sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

DE-111 ophthalmic solution

Tafluprost ophthalmic solution 0.0015%

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study

Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Secondary Outcome Measures

Full Information

NCT ID

NCT01342081

First Posted

April 25, 2011

Last Updated

May 19, 2015

Sponsor

Santen Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01342081

Brief Title

DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

Official Title

A Double-masked Study of DE-111 Ophthalmic Solution Versus Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5% in Patients With Primary Open Angle Glaucoma or Ocular Hypertension -Phase 3, Confirmatory Study-

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santen Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

Brief Summary

DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost 0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized, double-masked, parallel-group comparison study. Safety will be compared and evaluated as well.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma, Ocular Hypertension

Keywords

Primary open angle glaucoma or ocular hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Enrollment

489 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

DE-111 ophthalmic solution

Arm Title

Arm Type

Active Comparator

Arm Description

Tafluprost ophthalmic solution 0.0015%

Arm Title

Arm Type

Active Comparator

Arm Description

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Intervention Type

Drug

Intervention Name(s)

DE-111 ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

Tafluprost ophthalmic solution 0.0015%

Intervention Type

Drug

Intervention Name(s)

Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%

Primary Outcome Measure Information:

Title

Change From Baseline in Mean Diurnal IOP(Intraocular Pressure) at End of Study

Description

Mean diurnal IOP(intraocular pressure) was calculated as an average of IOP(intraocular pressure) at 9:30 (pre-dose), 11:30 and 17:30.

Time Frame

Week 0(Baseline) and Week 4(End of Study)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Eligibility Criteria

Inclusion Criteria: Diagnosed with primary open angle glaucoma or ocular hypertension Provided signed, written informed consent 20 years of age and older If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study. Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Facility Information:

Facility Name

Santen study sites

City

Osaka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%

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