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A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654484
First Posted: July 31, 2012
Last Update Posted: December 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santen Inc.
  Purpose
The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Condition Intervention Phase
Glaucoma and Ocular Hypertension Drug: DE-117 Drug: 0.0015% tafluprost Drug: DE-117 and 0.0015% tafluprost Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Santen Inc.:

Primary Outcome Measures:
  • Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point [ Time Frame: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs ]

Enrollment: 60
Study Start Date: July 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose DE-117
Monotherapy
Drug: DE-117
Ophthalmic Solution, QD, 28 Days
Experimental: Medium Dose DE-117
Monotherapy
Drug: DE-117
Ophthalmic Solution, QD, 28 Days
Experimental: High Dose DE-117
Monotherapy
Drug: DE-117
Ophthalmic Solution, QD, 28 Days
Experimental: Low Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
Drug: DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
Experimental: Med. Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
Drug: DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
Experimental: High Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
Drug: DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
Active Comparator: 0.0015% tafluprost
Monotherapy
Drug: 0.0015% tafluprost
Ophthalmic Solution, QD, 28 days
Placebo Comparator: Placebo
Monotherapy
Drug: Placebo
Ophthalmic Solution, QD, 28 days

Detailed Description:

This is a two stage study.

Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.

Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female, 18 years of age or older
  2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
  3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

  1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
  2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
  3. Females who are pregnant, nursing or planning a pregnancy
  4. Presence of any abnormality or significant illness that could be expected to interfere with the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01654484


Locations
United States, California
Santen Investigational Site
Newport Beach, California, United States, 92663
United States, Florida
Santen Investigational Site
Deerfield Beach, Florida, United States, 33064
Santen Investigational Site
Largo, Florida, United States, 33773
United States, Georgia
Santen Investigational Site
Morrow, Georgia, United States, 30260
Santen Investigational Site
Roswell, Georgia, United States, 30076
United States, New York
Santen Investigational Site
Rochester, New York, United States, 14618
United States, Ohio
Santen Investigational Site
Cleveland, Ohio, United States, 44115
United States, Texas
Santen Investigational Site
Austin, Texas, United States, 78731
Santen Investigational Site
Fort Worth, Texas, United States, 76102
Santen Investigational Site
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Santen Inc.
  More Information

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01654484     History of Changes
Other Study ID Numbers: 33-001
First Submitted: July 27, 2012
First Posted: July 31, 2012
Last Update Posted: December 17, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions