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Completed

NCT Number: NCT00643669

24 Hour IOP Lowering Efficacy of AL-3789

The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Inglewood

Inglewood, California, 90301, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Pregnant, intend to become pregnant, breastfeeding.
  • Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
  • Any form of glaucoma other than open-angle glaucoma.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AL-3789 Sterile Suspension

Drug

Single administration by anterior juxtascleral depot

Primary outcomes

  1. Mean Intraocular Pressure (IOP)

    Time frame: Day 28, Up to 24 hours

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Mar 26, 2008
Registry last updated
Nov 29, 2012

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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