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

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-210669 ophthalmic solution, 0.1%
AGN-210669 ophthalmic solution, 0.075%
AGN-210669 ophthalmic solution, 0.05%
bimatoprost ophthalmic solution 0.03%
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

AGN-210669 ophthalmic solution, 0.1%

AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05%

bimatoprost ophthalmic solution 0.03%

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Average Eye Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).

Secondary Outcome Measures

Full Information

First Posted
October 22, 2009
Last Updated
August 13, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01001195
Brief Title
Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-210669 ophthalmic solution, 0.1%
Arm Type
Experimental
Arm Description
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.
Arm Title
AGN-210669 ophthalmic solution, 0.075%
Arm Type
Experimental
Arm Description
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.
Arm Title
AGN-210669 ophthalmic solution, 0.05%
Arm Type
Experimental
Arm Description
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.
Arm Title
bimatoprost ophthalmic solution 0.03%
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
AGN-210669 ophthalmic solution, 0.1%
Intervention Description
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
Intervention Name(s)
AGN-210669 ophthalmic solution, 0.075%
Intervention Description
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
Intervention Name(s)
AGN-210669 ophthalmic solution, 0.05%
Intervention Description
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
Intervention Name(s)
bimatoprost ophthalmic solution 0.03%
Other Intervention Name(s)
LUMIGAN®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Eye Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
Time Frame
Baseline, Day 29 Hour 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Rochester
State/Province
New York
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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