A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma

Phase 2

Completed

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

• Registration Number: NCT00820300
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Disposition First Submitted: 2011-03-01
• Disposition First Submitted QC: 2011-03-01
• Disposition First Posted: 2011-03-16
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

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

Exclusion Criteria

• Subjects who wear contact lenses.
• Uncontrolled medical conditions
• 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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Punctal plug	Latanoprost-PPDS	-

Primary Outcome Measures

Name	Time	Method
IOP change from baseline	6 weeks