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

Phase 2

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost-PPDS

• Registration Number: NCT00650702
• Lead Sponsor: Mati Therapeutics Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-27
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Disposition First Submitted: 2011-02-23
• Disposition First Submitted QC: 2011-02-23
• Status Verified: 2011-03
• Disposition First Posted: 2011-03-02
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Over 18 yrs with open-angle glaucoma or ocular hypertension
• Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria

• Uncontrolled medical conditions.
• Subjects who wear contact lenses.
• Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
• Subjects who have a history of chronic or recurrent inflammatory eye disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Latanoprost-PPDS	Medium Latanoprost-PPDS
1	Latanoprost-PPDS	Low Latanoprost-PPDS
3	Latanoprost-PPDS	High Latanoprost-PPDS

Primary Outcome Measures

Name	Time	Method
IOP change from baseline	12 Weeks