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Completed

NCT Number: NCT01229982

A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma

The purpose of this study is to test if latanoprost punctal plugs will reduce eye pressure in subjects with ocular hypertension or open-angle glaucoma.

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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

QLT Inc.

Vancouver, British Columbia, V5T 4T5, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with bilateral OH or OAG and on topical prostaglandin monotherapy bilaterally as standard of care for treatment of OH or OAG.
  • Adequate IOP control on topical prostaglandin monotherapy during the past 1 month.

Exclusion criteria

  • Functionally significant vision loss, or progressive field loss within the last year.
  • Contact lens wear at any time during the treatment period.
  • Keratoconjunctivitis sicca requiring chronic topical artificial tears, lubricants, and/or Restasis®.
  • Active lid disease (i.e., moderate or severe blepharitis, meibomianitis) that requires medical treatment.
  • Subjects with ≥0.9 vertical cup or completely notched optic nerve head rim.
  • Currently on chronic ocular topical medications
  • Currently on any ophthalmic or systemic steroid therapy.
  • Laser surgery for glaucoma within the last 3 months or 6 months for incisional surgeries.
  • History of macular edema
  • History of chronic/recurrent inflammatory eye disease.
  • History of a non-response to topical prostaglandin therapy.
  • Subjects who have epiphora.

Treatment and study plan

Latanoprost-PPDS

Drug

Punctal Plug

Primary outcomes

  1. IOP change from baseline at 4 weeks

    Time frame: Baseline to 4 Weeks

    4 Weeks minus baseline

Sponsors and collaborators

Lead sponsor

Mati Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L PPDS)in Subjects With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG)

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2010
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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