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OpenTrials
Completed

NCT Number: NCT01037036

A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open-angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Menlo Park

Menlo Park, California, 94025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years
  • Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
  • Currently on prostaglandin therapy

Exclusion criteria

  • Uncontrolled medical conditions
  • Subjects who wear contact lenses
  • Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

Treatment and study plan

Latanoprost Punctal Plug Delivery System

Drug

To evaluate the control of IOP compared to baseline, for an experimental dose of Latanoprost Punctal Plug Delivery System for 4 week or until loss of efficacy. This is a single arm study.

Xalatan

Drug

Subjects will administer adjunctive Xalatan eye drops once daily for 2 weeks. This is a single arm study.

Primary outcomes

  1. Change from baseline in IOP measurements

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Mati Therapeutics Inc.

Industry

Collaborators

  • QLT Inc.

Registry information

Official study title

An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 21, 2009
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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