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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
QLT Inc.
ClinicalTrials.gov Identifier:
NCT01481051
First received: November 25, 2011
Last updated: October 3, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy, safety and duration of the L-PPDS (latanoprost punctal plug delivery system) at different dose levels.


Condition Intervention Phase
Glaucoma
Ocular Hypertension (OH)
 Drug: Latanoprost
 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: PPL GLAU 12: A Phase 2 Dose Evaluation Study for the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Resource links provided by NLM:

Drug Information available for: Latanoprost
U.S. FDA Resources

Further study details as provided by QLT Inc.:

Primary Outcome Measures:
  • IOP change from baseline [ Time Frame: 12 weeks to baseline ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: November 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Latanoprost
    Sustained delivery for 12 weeks
  Eligibility

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

Inclusion Criteria:

  • Male or female at least 18 years old
  • Diagnosis of bilateral open angle glaucoma or ocular hypertension
  • Unmedicated IOP must be ≥22mm Hg

Exclusion Criteria:

  • Any significant vision loss in the last year
  • No contact lens use for the length of the study
  • Abnormal eye lids, eye infection, or diseases to the eye
  • Recent eye surgery
  • Uncontrolled medication conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481051

Locations
United States, California
Sall Research Medical Center, Inc
Artesia, California, United States, 90701
Wolstan & Goldberg Eye Associates
Los Angeles, California, United States, 90505
West Coast Eye Care Associates
San Diego, California, United States, 92115
United States, Georgia
Coastal Research Associates, LLC
Roswell, Georgia, United States, 30076
United States, Texas
R and R Eye Associates
San Antonio, Texas, United States, 78229
United States, Utah
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
QLT Inc.
Investigators
Study Director: Suzanne Cadden QLT Inc.
  More Information

No publications provided

Responsible Party: QLT Inc.
ClinicalTrials.gov Identifier: NCT01481051     History of Changes
Other Study ID Numbers: PPL GLAU 12
Study First Received: November 25, 2011
Last Updated: October 3, 2012
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 23, 2013