Safety and Efficacy of AGN 210699 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00809848

Purpose

The study will evaluate the safety and efficacy of AGN 210669 ophthalmic solution in comparison with AGN 210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Condition	Intervention	Phase
Ocular Hypertension Glaucoma	Drug: AGN 210669 non-preserved ophthalmic solution Drug: AGN 210669 vehicle ophthalmic solution Drug: bimatoprost ophthalmic solution	Phase I Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

IOP change from Baseline [ Time Frame: Day 1 - Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean intraocular pressure [ Time Frame: Day 1- Day 14 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Experimental: 1 AGN 210669 non-preserved ophthalmic solution, 0.025%	Drug: AGN 210669 non-preserved ophthalmic solution AGN 210669 non-preserved ophthalmic solution, 0.025%. One drop in each eye each morning once-daily for 2 weeks.
Experimental: 2 AGN 210669 non-preserved ophthalmic solution, 0.05%	Drug: AGN 210669 non-preserved ophthalmic solution AGN 210669 non-preserved ophthalmic solution, 0.05%. One drop in each eye each morning once-daily for 2 weeks.
Experimental: 3 AGN 210669 non-preserved ophthalmic solution, 0.075%	Drug: AGN 210669 non-preserved ophthalmic solution AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.
Placebo Comparator: 4 AGN 210669 vehicle ophthalmic solution	Drug: AGN 210669 vehicle ophthalmic solution AGN 210669 vehicle ophthalmic solution. One drop in each eye each morning once-daily for 2 weeks.
Active Comparator: 5 0.03% bimatoprost ophthalmic solution	Drug: bimatoprost ophthalmic solution Bimatoprost 0.03% ophthalmic solution. One drop in each eye each morning once-daily for 2 weeks. Other Name: Lumigan®

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma
Females of non-childbearing potential
Subject requires IOP-lowering therapy in both eyes
IOP ≥ 22 mm Hg and ≤ 34 mm Hg
Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

Uncontrolled systemic disease
Active ocular disease
Alteration of existing chronic systemic medications
Known allergy or sensitivity to the study medications
Ophthalmic corticosteroids
Visual field loss which in the opinion of the investigator is functionally significant
History of ocular laser, intraocular surgery, or refractive surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809848

Locations

United States, California

Artesia, California, 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:	NCT00809848 History of Changes
Other Study ID Numbers:	210669-003
Study First Received:	December 16, 2008
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular 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 February 09, 2012