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Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

This study has been completed.
Sponsor:
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00845299
First received: February 16, 2009
Last updated: March 25, 2011
Last verified: March 2011
History of Changes
  Purpose

The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
 Drug: Latanoprost punctal plug
Drug: artificial tears preserved with Benzalkonium Chloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to 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 ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride
 Drug: Latanoprost punctal plug
Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.
Drug: artificial tears preserved with Benzalkonium Chloride
Experimental: 2
Latanoprost punctal plug only
 Drug: Latanoprost punctal plug
Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug 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 years 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 with a known sensitivity to latanoprost, BAK, or any other products required for the study
  • Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845299

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: NCT00845299     History of Changes
Other Study ID Numbers: PPL GLAU 04
Study First Received: February 16, 2009
Last Updated: March 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by QLT Inc.:
glaucoma
ocular hypertension

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

ClinicalTrials.gov processed this record on May 16, 2013