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

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DE-112

DE-112 Vehicle Solution

Timolol Maleate Solution

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Concentration 1

Concentration 2

Concentration 3

Concentration 4

Vehicle Solution

Timolol Maleate Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Intraocular pressure (IOP)

Change from baseline in mean diurnal IOP

Secondary Outcome Measures

Intraocular pressure (IOP)

Percent change from baseline in mean diurnal IOP

Full Information

NCT ID

NCT01279083

First Posted

January 14, 2011

Last Updated

December 14, 2012

Sponsor

Santen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01279083

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Santen Inc.

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Concentration 1

Arm Type

Experimental

Arm Title

Concentration 2

Arm Type

Experimental

Arm Title

Concentration 3

Arm Type

Experimental

Arm Title

Concentration 4

Arm Type

Experimental

Arm Title

Vehicle Solution

Arm Type

Placebo Comparator

Arm Title

Timolol Maleate Ophthalmic Solution

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

DE-112

Intervention Description

Topical ocular solution

Intervention Type

Drug

Intervention Name(s)

DE-112

Intervention Description

Topical ocular solution

Intervention Type

Drug

Intervention Name(s)

DE-112

Intervention Description

Topical ocular solution

Intervention Type

Drug

Intervention Name(s)

DE-112

Intervention Description

Topical ocular solution

Intervention Type

Drug

Intervention Name(s)

DE-112 Vehicle Solution

Intervention Description

Topical ocular solution

Intervention Type

Drug

Intervention Name(s)

Timolol Maleate Solution

Intervention Description

Topical ocular solution

Primary Outcome Measure Information:

Title

Intraocular pressure (IOP)

Description

Change from baseline in mean diurnal IOP

Time Frame

29 days

Secondary Outcome Measure Information:

Title

Intraocular pressure (IOP)

Description

Percent change from baseline in mean diurnal IOP

Time Frame

29 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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