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OpenTrials
Completed

NCT Number: NCT00845299

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

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.

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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

  • 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.

Treatment and study plan

Latanoprost punctal plug

Drug

Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.

artificial tears preserved with Benzalkonium Chloride

Drug

Primary outcomes

  1. IOP change from baseline

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Mati Therapeutics Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 18, 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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