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

• Sponsor: Mati Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01037036
• Collaborator: QLT Inc. (Industry)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension; Open-Angle Glaucoma	Drug: Latanoprost Punctal Plug Delivery System; Drug: Xalatan	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
• Study Start Date: Dec 1, 2009
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Latanoprost Punctal Plug Delivery System followed by 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.	Drug: Latanoprost Punctal Plug Delivery System; To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.; Drug: Xalatan; Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Outcome Measures

Primary Outcome Measures

1. Change from baseline in IOP measurements [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menlo Park	Menlo Park	California	United States	94025

Sponsors and Collaborators

• Mati Therapeutics Inc.
• QLT Inc.

Investigators

• Study Director: Oscar Cuzanni, MD, MSc, QLT Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mati Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT01037036
• Other Study ID Numbers: PPL GLAU 08
• First Posted: Dec 21, 2009
• Last Update Posted: Jan 10, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Mati Therapeutics Inc.: Ocular Hypertension; Open-Angle Glaucoma; Xalatan; IOP
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Latanoprost

Study Results

No Results Posted as of Jan 10, 2014