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Completed

NCT Number: NCT01114893

Travoprost Five Day Posology Study

The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.

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Key information

Conditions

Open-angle Glaucoma (OAG) 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

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • either sex and any race/ethnicity, ≥18 years old
  • diagnosed with open-angle glaucoma, and/or ocular hypertension
  • meets the following IOP entry criteria:
  • Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
  • Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
  • satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion criteria

  • females of childbearing potential not meeting protocol conditions
  • angle grade less than Grade 2 in either eye
  • cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
  • severe central visual field loss in either eye
  • any abnormality preventing reliable applanation tonometry in either eye
  • hypersensitivity to prostaglandin analogues or to any component of the study medication

Treatment and study plan

Travoprost 0.004%

Drug

1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days

Travoprost Vehicle

Drug

1 drop in each eye 8 times daily for 5 days

Travoprost (Groups A, B and C)

Drug

1 drop in each eye 8 times daily for 5 days

Primary outcomes

  1. Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5

    Time frame: 5 days

    Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment

Secondary outcomes

  1. IOP Change From Baseline at 8 PM on Day 5

    Time frame: 5 Days

    Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
First posted
May 3, 2010
Registry last updated
Jun 23, 2011

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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