A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

Phase 2

Completed

• Conditions: Ocular Hypertension; Open-Angle Glaucoma
• Interventions: Drug: Latanoprost Punctal Plug Delivery System; Drug: Xalatan

• Registration Number: NCT01037036
• Lead Sponsor: Mati Therapeutics Inc.

Brief Summary

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2010-04
• Study Completion: 2010-07
• Disposition First Submitted: 2011-06-17
• Disposition First Submitted QC: 2011-06-27
• Disposition First Posted: 2011-06-29
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Over 18 years
• Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
• Currently on prostaglandin therapy

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Latanoprost Punctal Plug Delivery System followed by Xalatan	Latanoprost Punctal Plug Delivery System	Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.
Latanoprost Punctal Plug Delivery System followed by Xalatan	Xalatan	Subjects will have the Latanoprost Punctal Plug Delivery System placed for 4 week or until loss of efficacy. After removal of the Latanoprost Punctal Plug Delivery system, subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Primary Outcome Measures

Name	Time	Method
Change from baseline in IOP measurements	4 weeks

Trial Locations

Locations (1)

Menlo Park; 🇺🇸 Menlo Park, California, United States