NCT00650702

Safety and Efficacy of Punctum Plug Delivery System in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase II, Randomized, Masked, Parallel-Group Study of Safety and Preliminary Efficacy of the Punctum Plug Delivery System in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Latanoprost-PPDS	Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy
DRUG	Latanoprost-PPDS	Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy
DRUG	Latanoprost-PPDS	Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2008-04-02
• Last updated: 2013-09-19

Locations

8 sites across 1 country: United States