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OpenTrials
Completed

NCT Number: NCT01016691

Safety and Efficacy of a Drug Delivery System in Glaucoma

Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Miami, Florida, 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
  • 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 Drug Device

Drug

device inserted for 4 days

Low Dose Drug Device

Drug

device inserted for 4 days

Placebo Device

Drug

device inserted for 4 days

bimatoprost 0.03%

Drug

one drop in each eye on one day only

Primary outcomes

  1. Mean Change in Intraocular Pressure at Day 1

    Time frame: Baseline to Day 1

Secondary outcomes

  1. Mean Change in Intraocular Pressure at Day 2

    Time frame: Baseline to Day 2

  2. Mean Change in Intraocular Pressure at Day 3

    Time frame: Baseline to Day 3

  3. Mean Change in Intraocular Pressure at Day 4

    Time frame: Baseline to Day 4

  4. Mean Change in Intraocular Pressure at Day 5

    Time frame: Day 4 to Day 5

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
First posted
Nov 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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