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

Browse trials for

• Glaucoma 1,818
• Ocular Hypertension 649
• Glaucoma, Open-Angle 929
• Hypertension 6,689

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 50 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Lead sponsor

Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.

Study arms

• Other
  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)

• Active comparator
  Timolol ophthalmic solution 0.5%

  timolol ophthalmic solution 0.5%

  Drug: timolol ophthalmic solution 0.5%

• Placebo comparator
  Placebo

  AGN-207281 vehicle ophthalmic solution (Placebo)

  Drug: AGN-207281 vehicle ophthalmic solution (Placebo)

Interventions

• DrugAGN-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.

• Drugtimolol 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

• DrugAGN-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.

Primary outcomes

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

   Time frame: Baseline, Day 14

Secondary outcomes

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

   Time frame: Day 7

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

   Time frame: Day 14

Baseline characteristics