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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Glaucoma, Open-Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type OTHER

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

Intervention Type 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%

timolol ophthalmic solution 0.5%

Group Type ACTIVE_COMPARATOR

timolol ophthalmic solution 0.5%

Intervention Type 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

Placebo

AGN-207281 vehicle ophthalmic solution (Placebo)

Group Type PLACEBO_COMPARATOR

AGN-207281 vehicle ophthalmic solution (Placebo)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No