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

Purpose

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.

Condition	Intervention	Phase
Ocular Hypertension Primary Open-Angle Glaucoma	Drug: Part 1: AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03% Drug: Part 1: AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03% Drug: Part 1: AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03% Drug: Part 1: AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03% Drug: Part 1: AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03% Drug: Part 1: AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03% Drug: Part 2: AGN-210961 Formulation to be selected from part 1 Drug: Part 2: bimatoprost ophthalmic solution 0.03%	Phase 2

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

Intraocular Pressure [ Time Frame: Part 1: Day 1,2,3,4,5,6,7, Part 2: Day 3, 8, 15, 22, 29 ] [ Designated as safety issue: No ]

Enrollment:	163
Study Start Date:	August 2010
Study Completion Date:	June 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Part 1, Arm 1 AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03%	Drug: Part 1: AGN-210961 Formulation 1 and bimatoprost ophthalmic solution 0.03% Part 1: One daily dose of AGN-210961 Formulation 1 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days Other Name: LUMIGAN®
Experimental: Part 1, Arm 2 AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03%	Drug: Part 1: AGN-210961 Formulation 2 and bimatoprost ophthalmic solution 0.03% Part 1: One daily dose of AGN-210961 Formulation 2 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days Other Name: LUMIGAN®
Experimental: Part 1, Arm 3 AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03%	Drug: Part 1: AGN-210961 Formulation 3 and bimatoprost ophthalmic solution 0.03% Part 1: One daily dose of AGN-210961 Formulation 3 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days Other Name: LUMIGAN®
Experimental: Part 1, Arm 4 AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03%	Drug: Part 1: AGN-210961 Formulation 4 and bimatoprost ophthalmic solution 0.03% Part 1: One daily dose of AGN-210961 Formulation 4 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days Other Name: LUMIGAN®
Experimental: Part 1, Arm 5 AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03%	Drug: Part 1: AGN-210961 Formulation 5 and bimatoprost ophthalmic solution 0.03% Part 1: One daily dose of AGN-210961 Formulation 5 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days Other Name: LUMIGAN®
Experimental: Part 1, Arm 6 AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03%	Drug: Part 1: AGN-210961 Formulation 6 and bimatoprost ophthalmic solution 0.03% Part 1: One daily dose of AGN-210961 Formulation 6 in study eye and bimatoprost ophthalmic solution 0.03% in fellow eye for 7 consecutive days Other Name: LUMIGAN®
Experimental: Part 2, Arm 1 AGN-210961 Formulation to be selected from part 1	Drug: Part 2: AGN-210961 Formulation to be selected from part 1 Part 2: One daily dose of AGN-210961 Formulation to be selected from part 1 in both eyes for 28 consecutive days
Active Comparator: Part 2, Arm 2 bimatoprost ophthalmic solution 0.03%	Drug: Part 2: bimatoprost ophthalmic solution 0.03% Part 2: One daily dose of bimatoprost ophthalmic solution 0.03% in both eyes 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

Exclusion Criteria:

Any active ocular disease
Anticipated wearing of contact lenses during study
Anticipated use of artificial tears during study
Contraindication to pupil dilatation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110499

Locations

United States, California

Newport Beach, California, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01110499 History of Changes
Other Study ID Numbers:	210961-002
Study First Received:	April 23, 2010
Last Updated:	May 25, 2012
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 May 19, 2013