Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001195
• Other study ID #: 210669-010
• Status: Completed
• Phase: Phase 2
• First received: October 22, 2009
• Last updated: August 13, 2013
• Start date: November 2009
• Est. completion date: April 2010

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

This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• 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

• Patient requires IOP lowering medication in each eye

Exclusion Criteria:

• Ocular hyperemia or other ocular surface findings in either eye

• Active ocular disease

• Current or anticipated use of any topical ocular medication (including artificial tears) during the study

• Intraocular surgery within past six months or unilateral cataract surgery.

• Functionally significant visual field loss

• Anticipated wearing of contact lenses during study

• Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit

Study Design

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

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension

Intervention

Drug:
• AGN-210669 ophthalmic solution, 0.1%
One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
• AGN-210669 ophthalmic solution, 0.075%
One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
• AGN-210669 ophthalmic solution, 0.05%
One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
• bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.

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 29 Hour 0	No