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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110499
• Other study ID #: 210961-002
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2010
• Last updated: July 10, 2014
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-Angle Glaucoma

Intervention

Drug:
• AGN-210961 Formulation 1
AGN-210961 Formulation 1 in one eye once daily for 7 days.
• AGN-210961 Formulation 2
AGN-210961 Formulation 2 in one eye once daily for 7 days.
• AGN-210961 Formulation 3
AGN-210961 Formulation 3 in one eye once daily for 7 days.
• AGN-210961 Formulation 4
AGN-210961 Formulation 4 in one eye once daily for 7 days.
• AGN-210961 Formulation 5
AGN-210961 Formulation 5 in one eye once daily for 7 days.
• AGN-210961 Formulation 6
AGN-210961 Formulation 6 in one eye once daily for 7 days.
• AGN-210961 Formulation 7
AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
• bimatoprost ophthalmic solution 0.03%
bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 7	No
Primary	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.	Baseline, Day 29	No