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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

Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma, Open-Angle; Ocular Hypertension

Intervention: 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) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

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

Primary outcome: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14

Secondary outcome:

Mean Concentration of AGN-207281 in Plasma at Day 7

Mean Concentration of AGN-207281 in Plasma at Day 14


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Newport Beach, California, United States
Additional Information

Starting date: October 2010
Last updated: July 22, 2015

Page last updated: August 23, 2015

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