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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01215786
First received: October 5, 2010
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
 Drug: AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)
Drug: timolol ophthalmic solution 0.5%
Drug: AGN-207281 vehicle ophthalmic solution (Placebo)
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]
    Change from baseline in worse eye IOP at day 14. Worse eye IOP refers to the eye with the worse (highest) baseline IOP (a measurement of the fluid pressure inside the eye). A negative number change from baseline indicates a reduction in IOP (improvement).


Secondary Outcome Measures:
  • Mean Concentration of AGN-207281 in Plasma at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
    Mean concentration of AGN-207281 in plasma at day 7. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 7, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.

  • Mean Concentration of AGN-207281 in Plasma at Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    Mean concentration of AGN-207281 in plasma at day 14. Plasma is the liquid component of the blood in which the blood cells are suspended. On day 14, the plasma sample collected 15 minutes post-morning dose from each patient receiving AGN-207281 was analyzed to determine the average drug concentration levels of AGN-207281.


Enrollment: 50
Study Start Date: October 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
AGN-207281 ophthalmic solution
AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
 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.
Active Comparator: Timolol ophthalmic solution 0.5%
timolol ophthalmic solution 0.5%
 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
Placebo Comparator: Placebo
AGN-207281 vehicle ophthalmic solution (Placebo)
 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.

  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
  • Requires IOP-lowering therapy in both eyes
  • Visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

  • Experienced significant weight change (over 10 pounds) within 60 days
  • History of alcohol or drug addiction
  • History of migraines or frequent headaches
  • Anticipated wearing of contact lenses during the study
  • Required chronic use of ocular medications during study
  • Eye surgery within 6 months
  • Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
  • Use of oral, intramuscular, intravenous corticosteroids within 21 days
  • Use of ophthalmic corticosteroids within 2 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01215786

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: NCT01215786     History of Changes
Other Study ID Numbers: 207281-004
Study First Received: October 5, 2010
Results First Received: December 8, 2011
Last Updated: December 8, 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
Timolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013