Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

Sponsor

Santen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01279083

Collaborator

(none)

147

Enrollment

Locations

Arms

Duration (Months)

73.5

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Ocular Hypertension	Drug: DE-112 Drug: DE-112 Drug: DE-112 Drug: DE-112 Drug: DE-112 Vehicle Solution Drug: Timolol Maleate Solution	Phase 1/Phase 2

Detailed Description

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Concentration 1	Drug: DE-112 Topical ocular solution
Experimental: Concentration 2	Drug: DE-112 Topical ocular solution
Experimental: Concentration 3	Drug: DE-112 Topical ocular solution
Experimental: Concentration 4	Drug: DE-112 Topical ocular solution
Placebo Comparator: Vehicle Solution	Drug: DE-112 Vehicle Solution Topical ocular solution
Active Comparator: Timolol Maleate Ophthalmic Solution	Drug: Timolol Maleate Solution Topical ocular solution

Outcome Measures

Primary Outcome Measures

Intraocular pressure (IOP) [29 days]
Change from baseline in mean diurnal IOP

Secondary Outcome Measures

Intraocular pressure (IOP) [29 days]
Percent change from baseline in mean diurnal IOP

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provide signed, written informed consent
18 yeas of age and older
Diagnosed with primary open-angle glaucoma or ocular hypertension
Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion Criteria:

Females who are pregnant, nursing or planning a pregnancy
Presence of any abnormality or significant illness that could be expected to interfere with the study.