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

Primary Purpose

Ocular Hypertension, Glaucoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGN-210669 ophthalmic solution, 0.075%
AGN-210669 ophthalmic solution, 0.05%
AGN-210669 ophthalmic solution, 0.025%
bimatoprost ophthalmic solution 0.03%
AGN-210669 vehicle ophthalmic solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

AGN-210669 ophthalmic solution, 0.075%

AGN-210669 ophthalmic solution, 0.05%

AGN-210669 ophthalmic solution, 0.025%

bimatoprost ophthalmic solution 0.03%

AGN-210669 vehicle ophthalmic solution

Arm Description

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

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

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%. One drop in both eyes each morning once-daily for 2 weeks.

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

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

Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.

Full Information

First Posted
December 16, 2008
Last Updated
August 13, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00809848
Brief Title
Safety and Efficacy of AGN 210669 Ophthalmic Solution in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-210669 ophthalmic solution, 0.075%
Arm Type
Experimental
Arm Description
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
Arm Title
AGN-210669 ophthalmic solution, 0.05%
Arm Type
Experimental
Arm Description
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
Arm Title
AGN-210669 ophthalmic solution, 0.025%
Arm Type
Experimental
Arm Description
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
Arm Title
bimatoprost ophthalmic solution 0.03%
Arm Type
Active Comparator
Arm Description
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Arm Title
AGN-210669 vehicle ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-210669 ophthalmic solution, 0.075%
Intervention Description
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-210669 ophthalmic solution, 0.05%
Intervention Description
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-210669 ophthalmic solution, 0.025%
Intervention Description
AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.03%
Other Intervention Name(s)
Lumigan®
Intervention Description
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-210669 vehicle ophthalmic solution
Intervention Description
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
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 14 Hour 0
Secondary Outcome Measure Information:
Title
Percentage of Patients With ≥ 20% Reduction From Baseline in Diurnal IOP
Description
IOP is a measurement of the fluid pressure inside the eye. Diurnal IOP is the average of the IOP values of both eyes at each time point measured at protocol-specified times throughout the day.
Time Frame
Baseline, Day 14

10. Eligibility

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

12. IPD Sharing Statement

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

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