A Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug Delivery System (L-PPDS)

Phase 2

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Latanoprost

• Registration Number: NCT00821002
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The study objective is to compare IOP and safety outcomes based on plug placement (upper or lower puncta).

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: 2009-11
• Study Completion: 2009-11
• 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: 32

Inclusion Criteria

• Over 18 years
• Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plug placement	Latanoprost	-

Primary Outcome Measures

Name	Time	Method
Intraocular pressure change from baseline (mmHg)	6 weeks

Secondary Outcome Measures

Name	Time	Method
Number of subjects with adverse events	6 weeks