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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809848
• Other study ID #: 210669-003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 16, 2008
• Last updated: August 13, 2013
• Start date: February 2009
• Est. completion date: May 2009

Study information

• Verified date: August 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• AGN-210669 ophthalmic solution, 0.075%
AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
• AGN-210669 ophthalmic solution, 0.05%
AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
• AGN-210669 ophthalmic solution, 0.025%
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%
Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
• AGN-210669 vehicle ophthalmic solution
AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 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	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).	Baseline, Day 14 Hour 0	No
Secondary	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.	Baseline, Day 14	No