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

Allergan

Status and phase: Completed; Phase 1

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

Treatments: 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)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01215786

207281-004

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups, including a placebo group

AGN-207281 ophthalmic solution

Other group

Description:

AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14

Treatment:

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

Timolol ophthalmic solution 0.5%

Active Comparator group

Description:

timolol ophthalmic solution 0.5%

Treatment:

Drug: timolol ophthalmic solution 0.5%

Placebo

Placebo Comparator group

Description:

AGN-207281 vehicle ophthalmic solution (Placebo)

Treatment:

Drug: AGN-207281 vehicle ophthalmic solution (Placebo)