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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279083
• Other study ID #: 29-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 14, 2011
• Last updated: December 14, 2012
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: February 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• DE-112
Topical ocular solution
• DE-112
Topical ocular solution
• DE-112
Topical ocular solution
• DE-112
Topical ocular solution
• DE-112 Vehicle Solution
Topical ocular solution
• Timolol Maleate Solution
Topical ocular solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP)	Change from baseline in mean diurnal IOP	29 days
Secondary	Intraocular pressure (IOP)	Percent change from baseline in mean diurnal IOP	29 days