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

This study has been completed.
Sponsor:
Collaborator:
QLT Inc.
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT01037036
First received: December 17, 2009
Last updated: December 10, 2013
Last verified: December 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT01037036     History of Changes
Other Study ID Numbers: PPL GLAU 08
Study First Received: December 17, 2009
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014