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

Phase 1

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: DE-112; Drug: DE-112 Vehicle Solution; Drug: Timolol Maleate Solution

• Registration Number: NCT01279083
• Lead Sponsor: Santen Inc.

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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2011-11
• Study Completion: 2012-02
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concentration 1	DE-112	-
Concentration 2	DE-112	-
Vehicle Solution	DE-112 Vehicle Solution	-
Timolol Maleate Ophthalmic Solution	Timolol Maleate Solution	-
Concentration 3	DE-112	-
Concentration 4	DE-112	-

Primary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	29 days	Change from baseline in mean diurnal IOP

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure (IOP)	29 days	Percent change from baseline in mean diurnal IOP