NCT01279083

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

10 months

First QC Date

January 14, 2011

Last Update Submit

December 14, 2012

Conditions

Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure (IOP)

    Change from baseline in mean diurnal IOP

    29 days

Secondary Outcomes (1)

  • Intraocular pressure (IOP)

    29 days

Study Arms (6)

Concentration 1

EXPERIMENTAL
Drug: DE-112

Concentration 2

EXPERIMENTAL
Drug: DE-112

Concentration 3

EXPERIMENTAL
Drug: DE-112

Concentration 4

EXPERIMENTAL
Drug: DE-112

Vehicle Solution

PLACEBO COMPARATOR
Drug: DE-112 Vehicle Solution

Timolol Maleate Ophthalmic Solution

ACTIVE COMPARATOR
Drug: Timolol Maleate Solution

Interventions

DE-112DRUG

Topical ocular solution

Concentration 1
DE-112 Vehicle SolutionDRUG

Topical ocular solution

Vehicle Solution
Timolol Maleate SolutionDRUG

Topical ocular solution

Timolol Maleate Ophthalmic Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide signed, written informed consent
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(2)