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A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG

This study has been completed.
Sponsor:
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00967811
First received: August 27, 2009
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: Formulation E1 of L-PPDS
Drug: Formulation E2 of L-PPDS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) 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: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Formulation E1
Formulation E1 of Latanoprost-PPDS
 Drug: Formulation E1 of L-PPDS
Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.
Experimental: 2. Formulation E2
Formulation E2 of Latanoprost-PPDS
 Drug: Formulation E2 of L-PPDS
Control of IOP compared to baseline for Formulation E2 of 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:

  • Subjects over 18 years of age diagnosed 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
  • Subjects who have uncontrolled medical conditions
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular 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: NCT00967811

Locations
United States, California
Menlo Park, California, United States, 94025
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: NCT00967811     History of Changes
Other Study ID Numbers: PPL GLAU 07
Study First Received: August 27, 2009
Last Updated: June 27, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
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