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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01110499
First received: April 23, 2010
Last updated: July 10, 2014
Last verified: July 2014
  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: AGN-210961 Formulation 1
Drug: AGN-210961 Formulation 2
Drug: AGN-210961 Formulation 3
Drug: AGN-210961 Formulation 4
Drug: AGN-210961 Formulation 5
Drug: AGN-210961 Formulation 6
Drug: AGN-210961 Formulation 7
Drug: 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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Part 1: Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.

  • Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP) [ Time Frame: Baseline, Day 29 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.


Enrollment: 163
Study Start Date: June 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, AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Drug: AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Drug: AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Drug: AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Drug: AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Drug: AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye once daily for 7 days.
Experimental: Part 1, AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Drug: AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye once daily for 7 days.
Experimental: Part 2, AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Drug: AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Active Comparator: Part 2, bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% 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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: May 31, 2013
Last Updated: July 10, 2014
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
Ophthalmic Solutions
Pharmaceutical Solutions
Bimatoprost
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014