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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Placebo; Drug: 0.005% latanoprost; Drug: DE-104 ophthalmic solution, low concentration; Drug: DE-104 ophthalmic solution, medium concentration; Drug: DE-104 ophthalmic solution, high concentration

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Los Angeles, California, United States, 90033
      • USC Department of Ophthalmology
    • Torrance, California, United States, 90505
      • Wolstan Eye Associates
  • Florida
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
  • Maryland
    • Bel Air, Maryland, United States, 21014
      • Seidenberg Protzko Eye Associates
  • Nebraska
    • Omaha, Nebraska, United States, 68198-5540
      • University of Nebraska Medical Center
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Associated Glaucoma Consultants
  • Texas
    • Austin, Texas, United States, 78731
      • Keystone Research, Ltd.
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • San Antonio, Texas, United States, 78209
      • Eye Clinics of South Texas
    • San Antonio, Texas, United States, 78209
      • David Shulman, MD P-A
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; <described in intervention>	Drug: DE-104 ophthalmic solution, low concentration; Topical ocular application
Experimental: 2; <described in intervention>	Drug: DE-104 ophthalmic solution, medium concentration; Topical ocular application
Experimental: 3; <described in intervention>	Drug: DE-104 ophthalmic solution, high concentration; Topical ocular application
Placebo Comparator: 4; <described in intervention>	Drug: Placebo; placebo
Active Comparator: 5; <described intervention>	Drug: 0.005% latanoprost; Topical ocular application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.	35 days

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 27, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): November 3, 2011
• Last Update Submitted That Met QC Criteria: November 1, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: 27-002