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NCT01342094 Clinical Trial

DE-111 Against Timolol Ophthalmic Solution 0.5%

Ocular Hypertension Clinical Trial

Official title:
A Double-masked Study of DE-111 Ophthalmic Solution Versus 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 NCT01342094
Other study ID # 01111005
Secondary ID
Status Completed
Phase Phase 3
First received April 24, 2011
Last updated June 14, 2015
Start date May 2011

Study information
Verified date June 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 Timolol ophthalmic solution 0.5%, 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 166
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

• Timolol ophthalmic solution 0.5%

• Placebo ophthalmic solution

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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