A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Santen Inc.14 sites in 1 country165 target enrollmentMarch 2008

ConditionsOpen-Angle Glaucoma Ocular Hypertension

InterventionsDE-104 ophthalmic solution, low concentration DE-104 ophthalmic solution, medium concentration DE-104 ophthalmic solution, high concentration Placebo 0.005% latanoprost

DrugsDE-104 ophthalmic solution, low concentration DE-104 ophthalmic solution, medium concentration DE-104 ophthalmic solution, high concentration Placebo 0.005% latanoprost

Overview

Phase: Phase 2
Intervention: DE-104 ophthalmic solution, low concentration
Conditions: Open-Angle Glaucoma
Sponsor: Santen Inc.
Enrollment: 165
Locations: 14
Primary Endpoint: To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

October 2008

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provided signed, written informed consent.
•Diagnosed with primary open-angle glaucoma or ocular hypertension.
•18 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.