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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291108
• Other study ID #: 210669-013
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2011
• Last updated: November 4, 2013
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: November 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• AGN-210669
AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
• bimatoprost
bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
• bimatoprost vehicle
bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.

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 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.	Baseline, Day 57	No
Secondary	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.	Baseline, Day 57	No