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A Phase 2 Study of the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study has been withdrawn prior to enrollment.
(Sponsor's decision)
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00855517
First received: March 2, 2009
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate IOP response to experimental dose of Latanoprost- PPDS in subjects with ocular hypertension or open-angle glaucoma.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Drug: Latanoprost-PPDS
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Partially Masked, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) 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:
  • IOP change from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Punctal Plug Drug: Latanoprost-PPDS
Control of IOP compared to baseline for the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 yrs of age 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 artifical tears, lubricants and/or requiring any other chronic topical medications
  • Subjects who have a history of chronic or recurrent inflammatory eye disease
  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: NCT00855517

Sponsors and Collaborators
Mati Therapeutics Inc.
Investigators
Study Director: Oscar Cuzzani, MD QLT Inc.
  More Information

No publications provided

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00855517     History of Changes
Other Study ID Numbers: PPL GLAU 06
Study First Received: March 2, 2009
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014