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

Glaucoma and Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654484
• Other study ID #: 33-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 27, 2012
• Last updated: April 16, 2018
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2018
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma and Ocular Hypertension
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• DE-117
Ophthalmic Solution, QD, 28 Days
• 0.0015% tafluprost
Ophthalmic Solution, QD, 28 days
• DE-117 and 0.0015% tafluprost
Ophthalmic Solutions, QD, 28 days
• Placebo
Ophthalmic Solution, QD, 28 days

Locations

Country	Name	City	State
United States	Santen Investigational Site	Austin	Texas
United States	Santen Investigational Site	Cleveland	Ohio
United States	Santen Investigational Site	Deerfield Beach	Florida
United States	Santen Investigational Site	Fort Worth	Texas
United States	Santen Investigational Site	Largo	Florida
United States	Santen Investigational Site	Morrow	Georgia
United States	Santen Investigational Site	Newport Beach	California
United States	Santen Investigational Site	Rochester	New York
United States	Santen Investigational Site	Roswell	Georgia
United States	Santen Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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