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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215786
• Other study ID #: 207281-004
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2010
• Last updated: July 22, 2015
• Start date: October 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Day 14	No
Secondary	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.	Day 7	No
Secondary	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.	Day 14	No