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OpenTrials
Completed

NCT Number: NCT00824720

Safety and Efficacy of a Glaucoma Drug Delivery System

The purpose of this study is to evaluate the ocular safety and efficacy of a glaucoma drug delivery system in open-angle glaucoma or ocular hypertension.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Artesia, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Man or woman 21 years of age or greater
  • must have open angle glaucoma or ocular hypertension.
  • Corrected visual acuity in each eye of 20/200 or better.

Exclusion criteria

  • Previous glaucoma intraocular surgery or refractive surgery.
  • Planned contact lens use during the study.
  • Clinically significant ocular or systemic disease that might interfere with the study.
  • Use of chronic corticosteroids by any route.

Treatment and study plan

High Dose Device

Drug

inserted for 14 days

Low Dose Device

Drug

inserted for 14 days

Placebo Device

Device

inserted for 14 days

Primary outcomes

  1. Visual Acuity - Right Eye

    Time frame: at 14 days

    This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR). The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

  2. Visual Acuity - Left Eye

    Time frame: at 14 days

    This outcome measures visual acuity in logMARs. logMAR is the logarithm of the minimum angle of resolution (logMAR. The ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.

Secondary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: from baseline to 14 days

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 19, 2009
Registry last updated
Mar 6, 2015

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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