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NCT01342081 Clinical 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%

Ocular Hypertension Clinical Trial

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-

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01342081
Other study ID # 01111004
Secondary ID
Status Completed
Phase Phase 3
First received April 25, 2011
Last updated May 19, 2015
Start date May 2011

Study information
Verified date May 2015
Source Santen Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 489
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• DE-111 ophthalmic solution

• Tafluprost ophthalmic solution 0.0015%

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

Locations
Country Name City State
Japan Santen study sites Osaka

Sponsors (1)
Lead Sponsor Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Week 0(Baseline) and Week 4(End of Study) Yes
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