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

NCT01520116 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2012-11-01

No results posted yet for this study

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

Interventions

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%

Sponsors & Collaborators

  • Altheos, Inc.

    lead INDUSTRY

Principal Investigators

  • Barbara Wirostko, MD · Altheos, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01520116 on ClinicalTrials.gov