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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT01110499 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2014-08-05

Study results available
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Summary

This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

Conditions

Interventions

DRUG

AGN-210961 Formulation 1

AGN-210961 Formulation 1 in one eye once daily for 7 days.

DRUG

AGN-210961 Formulation 2

AGN-210961 Formulation 2 in one eye once daily for 7 days.

DRUG

AGN-210961 Formulation 3

AGN-210961 Formulation 3 in one eye once daily for 7 days.

DRUG

AGN-210961 Formulation 4

AGN-210961 Formulation 4 in one eye once daily for 7 days.

DRUG

AGN-210961 Formulation 5

AGN-210961 Formulation 5 in one eye once daily for 7 days.

DRUG

AGN-210961 Formulation 6

AGN-210961 Formulation 6 in one eye once daily for 7 days.

DRUG

AGN-210961 Formulation 7

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

DRUG

bimatoprost ophthalmic solution 0.03%

bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-05-31
Completion
2011-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT01110499 on ClinicalTrials.gov