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Completed

NCT Number: NCT01215786

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 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.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)

Drug

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.

timolol ophthalmic solution 0.5%

Drug

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

AGN-207281 vehicle ophthalmic solution (Placebo)

Drug

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.

Primary outcomes

  1. Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14

    Time frame: Baseline, Day 14

    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 outcomes

  1. Mean Concentration of AGN-207281 in Plasma at Day 7

    Time frame: Day 7

    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.

  2. Mean Concentration of AGN-207281 in Plasma at Day 14

    Time frame: Day 14

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2010
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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