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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This study has been withdrawn prior to enrollment.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:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00855517
First received: March 2, 2009
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by QLT Inc.:

Primary Outcome Measures:
  • IOP change from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855517

Locations
United States, Florida
Miami, Florida, United States, 33176
Sponsors and Collaborators
QLT Inc.
Investigators
Study Director: Oscar Cuzzani, MD QLT Inc.
  More Information

No publications provided

Responsible Party: Study Manager, QLT Inc.
ClinicalTrials.gov Identifier: NCT00855517     History of Changes
Other Study ID Numbers: PPL GLAU 06
Study First Received: March 2, 2009
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013