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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma and Ocular Hypertension
• Intervention / Treatment: Drug: DE-117; Drug: DE-117 and 0.0015% tafluprost; Drug: 0.0015% tafluprost; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

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:

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Santen Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 27, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): July 31, 2012

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension
• Other Study ID Numbers: 33-001