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Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

NCT ID: NCT01001195

Last Updated: 2013-10-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

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This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

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-210669 ophthalmic solution, 0.1%

One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Group Type EXPERIMENTAL

AGN-210669 ophthalmic solution, 0.1%

Intervention Type DRUG

One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

AGN-210669 ophthalmic solution, 0.075%

One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Group Type EXPERIMENTAL

AGN-210669 ophthalmic solution, 0.075%

Intervention Type DRUG

One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

AGN-210669 ophthalmic solution, 0.05%

One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Group Type EXPERIMENTAL

AGN-210669 ophthalmic solution, 0.05%

Intervention Type DRUG

One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

bimatoprost ophthalmic solution 0.03%

One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Group Type ACTIVE_COMPARATOR

bimatoprost ophthalmic solution 0.03%

Intervention Type DRUG

One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Interventions

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AGN-210669 ophthalmic solution, 0.1%

One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Intervention Type DRUG

AGN-210669 ophthalmic solution, 0.075%

One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Intervention Type DRUG

AGN-210669 ophthalmic solution, 0.05%

One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

Intervention Type DRUG

bimatoprost ophthalmic solution 0.03%

One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

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
* Patient requires IOP lowering medication in each eye

Exclusion Criteria

* Ocular hyperemia or other ocular surface findings in either eye
* Active ocular disease
* Current or anticipated use of any topical ocular medication (including artificial tears) during the study
* Intraocular surgery within past six months or unilateral cataract surgery.
* Functionally significant visual field loss
* Anticipated wearing of contact lenses during study
* Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit
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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Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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210669-010

Identifier Type: -

Identifier Source: org_study_id