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OpenTrials
Completed

NCT Number: NCT00967811

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

  • 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

Treatment and study plan

Formulation E1 of L-PPDS

Drug

Control of IOP compared to baseline for Formulation E1 of the experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Formulation E2 of L-PPDS

Drug

Control of IOP compared to baseline for Formulation E2 of experimental dose of Latanoprost-PPDS for 6 weeks or until loss of efficacy.

Primary outcomes

  1. IOP change from baseline

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Mati Therapeutics Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 28, 2009
Registry last updated
Sep 19, 2013

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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