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 (Responsible Party):
Mati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00845299
First received: February 16, 2009
Last updated: September 16, 2013
Last verified: September 2013
  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:


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: 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
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: NCT00845299

Locations
United States, California
Menlo Park, California, United States, 94025
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: NCT00845299     History of Changes
Other Study ID Numbers: PPL GLAU 04
Study First Received: February 16, 2009
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mati Therapeutics 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 July 26, 2014