Safety and Efficacy of Three Formulations of AGN 210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution - Full Text View

Purpose

This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

Condition	Intervention	Phase
Primary Open-Angle Glaucoma	Drug: AGN-210669 0.05% ophthalmic solution Drug: AGN-210669 0.075% ophthalmic solution Drug: AGN-210669 0.1% ophthalmic solution Drug: bimatoprost 0.03% ophthalmic solution	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Intraocular pressure (IOP) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	November 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AGN-210669 0.05% ophthalmic solution	Drug: AGN-210669 0.05% ophthalmic solution One drop in each eye each evening from Day 1 through the evening prior to Day 29. Selected sites: One drop in each eye each evening from Day 1 to Day 29.
Experimental: 2 AGN-210669 0.075% ophthalmic solution	Drug: AGN-210669 0.075% ophthalmic solution One drop in each eye each evening from Day 1 through the evening prior to Day 29. Selected sites: One drop in each eye each evening from Day 1 to Day 29.
Experimental: 3 AGN-210669 0.1% ophthalmic solution	Drug: AGN-210669 0.1% ophthalmic solution One drop in each eye each evening from Day 1 through the evening prior to Day 29. Selected sites: One drop in each eye each evening from Day 1 to Day 29.
Experimental: 4 bimatoprost 0.03% ophthalmic solution	Drug: bimatoprost 0.03% ophthalmic solution One drop in each eye each evening from Day 1 through the evening prior to Day 29. Selected sites: One drop in each eye each evening from Day 1 to Day 29. Other Name: LUMIGAN®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Patient requires IOP lowering medication in each eye

Exclusion Criteria:

Ocular hyperemia or other ocular surface findings in either eye
Active ocular disease
Current or anticipated use of any topical ocular medication (including artificial tears) during the study
Intraocular surgery within past six months or unilateral cataract surgery.
Functionally significant visual field loss
Anticipated wearing of contact lenses during study
Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001195

Locations

United States, New York

Rochester, New York, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT01001195 History of Changes
Other Study ID Numbers:	210669-010
Study First Received:	October 22, 2009
Last Updated:	May 3, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013