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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:
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT01654484
First received: July 27, 2012
Last updated: December 14, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

Drug Information available for: Tafluprost
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT01654484     History of Changes
Other Study ID Numbers: 33-001
Study First Received: July 27, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013