NCT01896180

Study to Compare the Safety and Efficacy of ALZ-1101 to Latanoprost in Patients With Intraocular Pressure Inadequately Controlled by Latanoprost

A Pilot, Single-Masked Study to Compare the Safety and Efficacy of ALZ-1101 (Latanoprost 0.005%/Dorzolamide 2.0%) to Latanoprost Ophthalmic Solution, 0.005% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension With Intraocular Pressure Inadequately Controlled By Latanoprost

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Alleanza Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, proof of concept study to evaluate the safety and efficacy of ALZ-1101 dosed once daily for 28 days compared to latanoprost 0.005% ophthalmic solution in patients with elevated intraocular pressure not adequately controlled with latanoprost.

Detailed description

This is an exploratory, pilot, proof of concept Phase 2 study. The objectives include the comparison of efficacy of ALZ-1101 to latanoprost 0.005% ophthalmic solution in reducing elevated intraocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension who have IOP not adequately controlled with latanoprost. 70 Subjects (35 per arm) will be treated once daily (QD) in the evening with either ALZ-1101 or latanoprost for 28 days. Efficacy will be assessed at 3 separate times (8 AM, 10 AM and 4 PM) on each treatment visit (Days 0, 7, 14 and 28) by Goldmann applanation tonometry. Safety assessments will include slit lamp examination/anterior chamber cell and flare grading, ophthalmoscopy/fundus examination, visual acuity, visual field testing and colelction of adverse events. Subject rating of study medication comfort will be collected at each visit. Primary efficacy endpoint is the between-group comparison of the mean IOP at the 10 am time point at visit 5 (Day 28). Secondary endpoints include the between-group comparisons of the mean change from baseline in IOP at all time-points, between group comparison of the mean change from baseline in diurnal IOP at all post-baseline visits and the proportion of subjects with IOP ≤ 18 mm Hg at all time points at all post-baseline visits.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension
• Elevated Intraocular Pressure

Interventions

Type	Name	Description
DRUG	ALZ-1101	ALZ-1101 Ophthalmic Solution
DRUG	Latanoprost	Latanoprost 0.005% Ophthalmic Solution

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-07-11
• Last updated: 2014-09-30

Locations

1 site across 1 country: United States