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

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-210669
bimatoprost
bimatoprost vehicle
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:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
  • Requires bilateral treatment with an IOP-lowering medication
  • Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

  • Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
  • Inability to fast for up to 10 hours
  • Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
  • Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
  • Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
  • Anticipated wearing of contact lenses during study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Experimental

Other

Arm Label

AGN-210669

AGN-210669 + bimatoprost

AGN-210669 + bimatoprost vehicle

bimatoprost

bimatoprost + AGN-210669

bimatoprost + bimatoprost vehicle

Arm Description

AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.

AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.

AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.

bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.

bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.

bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.

Outcomes

Primary Outcome Measures

Change From Baseline in Average Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12.

Secondary Outcome Measures

Change From Baseline in Worse Eye IOP
IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 8, and 12.

Full Information

First Posted
February 4, 2011
Last Updated
November 4, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01291108
Brief Title
Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (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 and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-210669
Arm Type
Experimental
Arm Description
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
Arm Title
AGN-210669 + bimatoprost
Arm Type
Experimental
Arm Description
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Arm Title
AGN-210669 + bimatoprost vehicle
Arm Type
Experimental
Arm Description
AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Arm Title
bimatoprost
Arm Type
Active Comparator
Arm Description
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
Arm Title
bimatoprost + AGN-210669
Arm Type
Experimental
Arm Description
bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
Arm Title
bimatoprost + bimatoprost vehicle
Arm Type
Other
Arm Description
bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
Intervention Type
Drug
Intervention Name(s)
AGN-210669
Intervention Description
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Intervention Type
Drug
Intervention Name(s)
bimatoprost
Other Intervention Name(s)
LUMIGAN®
Intervention Description
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
Intervention Type
Drug
Intervention Name(s)
bimatoprost vehicle
Intervention Description
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
Primary Outcome Measure Information:
Title
Change From Baseline in Average Eye IOP
Description
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes are 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). Data are recorded at Hours 0, 4, 8, and 12.
Time Frame
Baseline, Day 57
Secondary Outcome Measure Information:
Title
Change From Baseline in Worse Eye IOP
Description
IOP is a measurement of the fluid pressure inside the eye. The worse eye IOP refers to eye with the worse baseline IOP, which is determined as the eye with the higher mean diurnal IOP at baseline. If both eyes have the same mean diurnal IOP at baseline, the right eye is designated as the worse eye. 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). Data are recorded at Hours 0, 4, 8, and 12.
Time Frame
Baseline, Day 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye Requires bilateral treatment with an IOP-lowering medication Best corrected visual acuity of 20/100 or better in each eye Exclusion Criteria: Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months Inability to fast for up to 10 hours Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy) Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months Current or anticipated use of artificial tears or any ocular medications aside from study medications during study Anticipated wearing of contact lenses during study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Austin
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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

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