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OpenTrials
Completed

NCT Number: NCT01298687

Divided Dose of TRAVATAN®

The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:
  • Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
  • Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
  • Must sign an informed consent form.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
  • Current or history of ocular inflammation or infection in either eye within the past 3 months.
  • Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
  • Severe visual field loss.
  • Cup to disc ratio greater than 0.8 in either eye.
  • Intraocular surgery within the past 6 months in either eye.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Travoprost Ophthalmic Solution, 0.00013%

Drug

Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose

Travoprost Ophthalmic Solution, 0.00033%

Drug

Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose

Travoprost ophthalmic solution, 0.001%

Drug

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

Travoprost Ophthalmic Solution, 0.00267%

Drug

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

Travoprost ophthalmic solution, 0.004%

Drug

Other names: TRAVATAN®

Travoprost Vehicle

Drug

Inactive ingredients used as an active comparator

Primary outcomes

  1. 24-hour Area Under the Curve (AUC) in IOP Reduction

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2011
Registry last updated
May 5, 2017

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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