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Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma

NCT ID: NCT00809848

Last Updated: 2013-10-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-05-31

Brief Summary

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The study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution in comparison with AGN-210669 vehicle and bimatoprost ophthalmic solution dosed once-daily each morning, in subjects with ocular hypertension or primary open-angle glaucoma. Subjects will be followed for 2 weeks.

Detailed Description

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Conditions

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Ocular Hypertension Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AGN-210669 ophthalmic solution, 0.075%

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

Group Type EXPERIMENTAL

AGN-210669 ophthalmic solution, 0.075%

Intervention Type DRUG

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.05%

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

Group Type EXPERIMENTAL

AGN-210669 ophthalmic solution, 0.05%

Intervention Type DRUG

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 ophthalmic solution, 0.025%

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

Group Type EXPERIMENTAL

AGN-210669 ophthalmic solution, 0.025%

Intervention Type DRUG

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

bimatoprost ophthalmic solution 0.03%

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

Group Type ACTIVE_COMPARATOR

bimatoprost ophthalmic solution 0.03%

Intervention Type DRUG

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

AGN-210669 vehicle ophthalmic solution

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Group Type PLACEBO_COMPARATOR

AGN-210669 vehicle ophthalmic solution

Intervention Type DRUG

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.

Interventions

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AGN-210669 ophthalmic solution, 0.075%

AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.

Intervention Type DRUG

AGN-210669 ophthalmic solution, 0.05%

AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.

Intervention Type DRUG

AGN-210669 ophthalmic solution, 0.025%

AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.

Intervention Type DRUG

bimatoprost ophthalmic solution 0.03%

Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.

Intervention Type DRUG

AGN-210669 vehicle ophthalmic solution

AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 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
* Females of non-childbearing potential
* Subject requires IOP-lowering therapy in both eyes
* IOP ≥ 22 mm Hg and ≤ 34 mm Hg
* Has a visual acuity score of 20/100 or better in each eye

Exclusion Criteria

* Uncontrolled systemic disease
* Active ocular disease
* Alteration of existing chronic systemic medications
* Known allergy or sensitivity to the study medications
* Ophthalmic corticosteroids
* Visual field loss which in the opinion of the investigator is functionally significant
* History of ocular laser, intraocular surgery, or refractive surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Artesia, California, United States

Site Status

Countries

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United States

Other Identifiers

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210669-003

Identifier Type: -

Identifier Source: org_study_id