NCT01520116

Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension

A Phase 1/2a Randomized, Investigator-masked, Placebo- and Active-controlled, Dose-ranging Study of the Safety and Efficacy of ATS907 in Subjects With Primary Open Angle Glaucoma (POAG) and Ocular Hypertension

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Altheos, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized dose-ranging study will evaluate the safety, tolerability, and preliminary efficacy (reduction in intraocular pressure) of multiple dose levels of ATS907, vehicle, or latanoprost in subjects with primary open angle glaucoma or ocular hypertension. In the first portion, approximately 75 subjects will be randomized to receive either ATS907 or vehicle eye drops for up to 28 days, administered both once and twice daily. In the second portion, up to 180 subjects will be randomized to receive either ATS907 or latanoprost for up to 28 days. Plasma pharmacokinetics will also be evaluated during the first portion of the study.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Stage 1 - ATS907 - Dose 1	QD and/or BID dosing for 28 days
DRUG	Stage 1 - ATS907 - Dose 2	QD and/or BID dosing for 28 days
DRUG	Stage 1 - ATS907 - Dose 3	QD and/or BID dosing for 28 days
DRUG	Stage 1 - ATS907 - Dose 4	QD and/or BID dosing for 28 days
DRUG	Stage 1 - Vehicle	QD and/or BID dosing for 28 days
DRUG	Stage 2 - ATS907 - Dose A - to be selected based on Stage 1	QD and/or BID dosing for 4 days
DRUG	Stage 2 - ATS907 - Dose B - to be selected based on Stage 1	QD and/or BID dosing for 4 days
DRUG	Timoptic	0.5%

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• First posted: 2012-01-27
• Last updated: 2012-11-01

Locations

5 sites across 1 country: United States