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

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.
 
ClinicalTrials.gov Identifier: NCT00821002
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : September 19, 2013
Sponsor:
Collaborator:
QLT Inc.
Information provided by (Responsible Party):
Mati Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Latanoprost Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2 Study of Punctal Placement of the Latanoprost Punctal Plug System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study Start Date : January 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: Plug placement Drug: Latanoprost
Comparison of punctal plug placement between upper and lower puncta




Primary Outcome Measures :
  1. Intraocular pressure change from baseline (mmHg) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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

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

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): NCT00821002


Locations
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United States, California
Menlo Park, California, United States, 94025
Sponsors and Collaborators
Mati Therapeutics Inc.
QLT Inc.
Investigators
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Study Director: Oscar Cuzanni, MD, MSc QLT Inc.
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Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00821002    
Other Study ID Numbers: PPL GLAU 05
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013
Keywords provided by Mati Therapeutics Inc.:
Glaucoma
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents