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Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

Primary Purpose

Ocular Hypertension, Primary Open-Angle Glaucoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AGN-210961 Formulation 1
AGN-210961 Formulation 2
AGN-210961 Formulation 3
AGN-210961 Formulation 4
AGN-210961 Formulation 5
AGN-210961 Formulation 6
AGN-210961 Formulation 7
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 Ocular Hypertension

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

Exclusion Criteria:

  • Any active ocular disease
  • Anticipated wearing of contact lenses during study
  • Anticipated use of artificial tears during study
  • Contraindication to pupil dilatation

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Part 1, AGN-210961 Formulation 1

Part 1, AGN-210961 Formulation 2

Part 1, AGN-210961 Formulation 3

Part 1, AGN-210961 Formulation 4

Part 1, AGN-210961 Formulation 5

Part 1, AGN-210961 Formulation 6

Part 2, AGN-210961 Formulation 7

Part 2, bimatoprost ophthalmic solution 0.03%

Arm Description

AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.

AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.

bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.

Outcomes

Primary Outcome Measures

Part 1: Change From Baseline in Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2010
Last Updated
July 10, 2014
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01110499
Brief Title
Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 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 has 2 parts. Part 1 will evaluate the safety and IOP effects of 6 formulations of AGN-210961 ophthalmic solution in the study eye and bimatoprost ophthalmic solution 0.03% in the fellow eye for 7 consecutive days. Part 2 will evaluate the safety and IOP effects of a formulation (to be selected from part 1) of AGN-210961 in both eyes compared to bimatoprost ophthalmic solution 0.03% for 4 weeks.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1, AGN-210961 Formulation 1
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Arm Title
Part 1, AGN-210961 Formulation 2
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Arm Title
Part 1, AGN-210961 Formulation 3
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Arm Title
Part 1, AGN-210961 Formulation 4
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Arm Title
Part 1, AGN-210961 Formulation 5
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Arm Title
Part 1, AGN-210961 Formulation 6
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
Arm Title
Part 2, AGN-210961 Formulation 7
Arm Type
Experimental
Arm Description
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Arm Title
Part 2, bimatoprost ophthalmic solution 0.03%
Arm Type
Active Comparator
Arm Description
bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 1
Intervention Description
AGN-210961 Formulation 1 in one eye once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 2
Intervention Description
AGN-210961 Formulation 2 in one eye once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 3
Intervention Description
AGN-210961 Formulation 3 in one eye once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 4
Intervention Description
AGN-210961 Formulation 4 in one eye once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 5
Intervention Description
AGN-210961 Formulation 5 in one eye once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 6
Intervention Description
AGN-210961 Formulation 6 in one eye once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
AGN-210961 Formulation 7
Intervention Description
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
bimatoprost ophthalmic solution 0.03%
Other Intervention Name(s)
LUMIGAN®
Intervention Description
bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
Primary Outcome Measure Information:
Title
Part 1: Change From Baseline in Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. Data are recorded at Hours 0, 2, 4, 6, 8, and 12. A negative number change from Baseline indicated a reduction in IOP (improvement). Data for bimatoprost-treated eyes are combined across groups.
Time Frame
Baseline, Day 7
Title
Part 2: Change From Baseline in Average Eye Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the eye. Average IOP is the average of the 2 eyes for each patient at each time point. A negative number change from Baseline indicates a reduction in IOP (improvement). Data are recorded at Hours 0, 2, 4, 6, 8, and 12.
Time Frame
Baseline, Day 29

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 Exclusion Criteria: Any active ocular disease Anticipated wearing of contact lenses during study Anticipated use of artificial tears during study Contraindication to pupil dilatation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of AGN-210961 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

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