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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT ID: NCT01110499

Last Updated: 2014-08-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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This study has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

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Detailed Description

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Conditions

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Ocular Hypertension Primary Open-Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1, AGN-210961 Formulation 1

AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Group Type EXPERIMENTAL

AGN-210961 Formulation 1

Intervention Type DRUG

AGN-210961 Formulation 1 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 2

AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Group Type EXPERIMENTAL

AGN-210961 Formulation 2

Intervention Type DRUG

AGN-210961 Formulation 2 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 3

AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Group Type EXPERIMENTAL

AGN-210961 Formulation 3

Intervention Type DRUG

AGN-210961 Formulation 3 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 4

AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Group Type EXPERIMENTAL

AGN-210961 Formulation 4

Intervention Type DRUG

AGN-210961 Formulation 4 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 5

AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Group Type EXPERIMENTAL

AGN-210961 Formulation 5

Intervention Type DRUG

AGN-210961 Formulation 5 in one eye once daily for 7 days.

Part 1, AGN-210961 Formulation 6

AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

Group Type EXPERIMENTAL

AGN-210961 Formulation 6

Intervention Type DRUG

AGN-210961 Formulation 6 in one eye once daily for 7 days.

Part 2, AGN-210961 Formulation 7

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Group Type EXPERIMENTAL

AGN-210961 Formulation 7

Intervention Type DRUG

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Part 2, bimatoprost ophthalmic solution 0.03%

bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Group Type ACTIVE_COMPARATOR

bimatoprost ophthalmic solution 0.03%

Intervention Type DRUG

bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Interventions

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AGN-210961 Formulation 1

AGN-210961 Formulation 1 in one eye once daily for 7 days.

Intervention Type DRUG

AGN-210961 Formulation 2

AGN-210961 Formulation 2 in one eye once daily for 7 days.

Intervention Type DRUG

AGN-210961 Formulation 3

AGN-210961 Formulation 3 in one eye once daily for 7 days.

Intervention Type DRUG

AGN-210961 Formulation 4

AGN-210961 Formulation 4 in one eye once daily for 7 days.

Intervention Type DRUG

AGN-210961 Formulation 5

AGN-210961 Formulation 5 in one eye once daily for 7 days.

Intervention Type DRUG

AGN-210961 Formulation 6

AGN-210961 Formulation 6 in one eye once daily for 7 days.

Intervention Type DRUG

AGN-210961 Formulation 7

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

Intervention Type DRUG

bimatoprost ophthalmic solution 0.03%

bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Intervention Type DRUG

Other Intervention Names

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LUMIGAN®

Eligibility Criteria

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Inclusion Criteria

\- Ocular hypertension or primary open-angle glaucoma in each eye

Exclusion Criteria

* Any active ocular disease
* Anticipated wearing of contact lenses during study
* Anticipated use of artificial tears during study
* Contraindication to pupil dilatation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Newport Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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210961-002

Identifier Type: -

Identifier Source: org_study_id

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