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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01037036
First Posted: December 21, 2009
Last Update Posted: January 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
QLT Inc.
Information provided by (Responsible Party):
Mati Therapeutics Inc.
  Purpose
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 Intervention Phase
Ocular Hypertension Open-Angle Glaucoma Drug: Latanoprost Punctal Plug Delivery System Drug: Xalatan Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Mati Therapeutics Inc.:

Primary Outcome Measures:
  • Change from baseline in IOP measurements [ Time Frame: 4 weeks ]

Enrollment: 15
Study Start Date: December 2009
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01037036


Locations
United States, California
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.
  More Information

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01037036     History of Changes
Other Study ID Numbers: PPL GLAU 08
First Submitted: December 17, 2009
First Posted: December 21, 2009
Last Update Posted: January 10, 2014
Last Verified: December 2013

Keywords provided by Mati Therapeutics Inc.:
Ocular Hypertension
Open-Angle Glaucoma
Xalatan
IOP

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Tetrahydrozoline
Latanoprost
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents