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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

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ClinicalTrials.gov Identifier: NCT00845299
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
Mati Therapeutics Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Latanoprost punctal plug Drug: artificial tears preserved with Benzalkonium Chloride Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. IOP change from baseline [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Mati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00845299     History of Changes
Other Study ID Numbers: PPL GLAU 04
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Mati Therapeutics Inc.:
glaucoma
ocular hypertension

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Lubricant Eye Drops
Benzalkonium Compounds
Antihypertensive Agents
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents