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Completed

NCT Number: NCT01318252

AL-54478 Proof of Concept Study

The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.

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Key information

Conditions

Open-angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension Ocular Hypertension (OHT)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with either OAG or OHT.
  • Patients who are able to comply with the scheduled visits.
  • Patients who have had a physical exam within 6 months of the Screening Visit.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
  • Patients with extreme narrow angle with complete or partial closure.
  • Patients with a cup to disc ratio more than 0.8.
  • Patients with a severe central visual field loss in either eye.
  • Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
  • Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months.
  • Patients with best-correct visual acuity less than 20/80.
  • Patients who have had ocular infection or inflammation within the past 3 months.
  • Patients who have clinically relevant progressive retinal disease.
  • Patients who have severe illness or conditions.
  • Patients who have hypersensitivity to a prostaglandin analogu.e
  • Patients who are unable to safely discontinue all IOP-lowering medications during washout.
  • Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

AL-54478 0.005%

Drug

Latanoprost 0.005%

Drug

AL-54478 Vehicle

Drug

Inactive ingredients used as a placebo comparator

Primary outcomes

  1. 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2011
Registry last updated
Jul 31, 2014

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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