Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

Official Title: “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”

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

Intervention(s) in this Clinical Trial

• Drug: DE-104 ophthalmic solution, low concentration
  • Topical ocular application
• Drug: DE-104 ophthalmic solution, medium concentration
  • Topical ocular application
• Drug: DE-104 ophthalmic solution, high concentration
  • Topical ocular application
• Drug: Placebo
  • placebo
• Drug: 0.005% latanoprost
  • Topical ocular application

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • <described in intervention>
• Experimental: 2
  • <described in intervention>
• Experimental: 3
  • <described in intervention>
• Placebo Comparator: 4
  • <described in intervention>
• Active Comparator: 5
  • <described intervention>

Primary Measures

• To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.
  • Time Frame: 35 days
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Santen Inc. Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650338

Study ID Number: 27-002

ClinicalTrials.gov Identifier: NCT00650338

Health Authority: United States: Food and Drug Administration