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A Safety Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open Angle Glaucoma

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: NCT00820300
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.

Brief Summary:
The purpose of this study is to determine if the Punctal Plug Delivery System is safe and effective in controlling intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
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) in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: Punctal plug Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the experimental doses of Latanoprost-PPDS for 4 months or until loss of efficacy.




Primary Outcome Measures :
  1. IOP change from baseline [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 yrs with ocular hypertension or open-angle glaucoma
  • Subjects who have a best-corrected visual acuity of 20/100 or better.

Exclusion Criteria:

  • Subjects who wear contact lenses.
  • Uncontrolled medical conditions
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
  • Subjects who have a history of chronic or recurrent inflammatory eye disease.

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): NCT00820300


Locations
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United States, California
Menlo Park, California, United States, 94025
Sponsors and Collaborators
Mati Therapeutics Inc.
Investigators
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Study Director: Oscar Cuzzani, MD QLT Inc.
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Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00820300    
Other Study ID Numbers: PPL GLAU 03
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents