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Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

NCT01215786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-08-17

Study results available
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Summary

This is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.

Conditions

Interventions

DRUG

AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)

One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.

DRUG

timolol ophthalmic solution 0.5%

One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days

DRUG

AGN-207281 vehicle ophthalmic solution (Placebo)

One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.

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
2010-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT01215786 on ClinicalTrials.gov