DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Open Angle Glaucoma or Ocular Hypertension Clinical Trial

Official title:

A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343082
• Other study ID #: 01111006
• Status: Completed
• Phase: Phase 3
• First received: April 24, 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

Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. primary completion date: March 2013
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with 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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma or Ocular Hypertension

Intervention

Drug:
• DE-111 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 IOP (Intraocular Pressure) at End of Study		Treatment period: Week 0 (Baseline) and Week 52 (End of Study)	Yes