Travacom Post Marketing Surveillance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01510132
Recruitment Status : Withdrawn
First Posted : January 13, 2012
Last Update Posted : October 18, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of Travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other intraocular pressure-lowering (IOP) medication and when use of Travacom is considered appropriate.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost/timolol fixed combination (Travacom) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Marketing Surveillance Study to Evaluate the Safety Profile of Travacom (Travoprost/Timolol Fixed Combination) in Patients With Open-Angle Glaucoma or Ocular Hypertension Across India
Study Start Date : January 2012
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Arm Intervention/treatment
Experimental: Travacom
Travoprost/timolol fixed combination self-administered at the rate of 1 drop per eye, one time a day, at approximately 8 a.m. each day for 8 weeks.
Drug: Travoprost/timolol fixed combination (Travacom)
Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension
Other Name: Travacom

Primary Outcome Measures :
  1. Extent of exposure [ Time Frame: Up to 8 weeks ]
    Extent of exposure is calculated as days on therapy. Days on therapy is defined as the difference in days between the date of exit (last) instillation as recorded on the last visit and the visit at which medication was first administered.

  2. Adverse events [ Time Frame: Up to 8 weeks ]
    Any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. Adverse events will be collected spontaneously and systematically at each scheduled study visit and may be collected at any unscheduled visit that occurs during the study. Adverse events will be documented on Adverse Events Forms and will be reported by MedDRA preferred terminology.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older.
  • Open-angle glaucoma or ocular hypertension insufficiently responsive to betablockers, prostaglandins, or other intraocular pressure-lowering (IOP) agents and when the use of Travacom is considered appropriate.
  • Discontinued use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
  • Mean IOP not greater than 36 mmHG in either eye.
  • Read, sign, and date (or legal representative) the Informed Consent prior to the start of any study-related procedures.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential (not postmenopausal for at least one year or not surgically sterile) who are currently pregnant, have a positive result on the urine pregnancy test at Screening, intend to become pregnant during the study period, are breastfeeding, or do not agree to use an adequate birth control method to prevent pregnancy throughout the study.
  • Chronic, recurrent, or severe inflammatory eye disease, such as scleritis, uveitis, or herpes keratitis.
  • History of clinically significant or progressive retinal disease.
  • Best corrected visual acuity (BCVA) score worse than 20/80 Snellen.
  • Bronchial asthma or related history that would preclude safe administration of a topical beta-blocker.
  • Severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease or related history that would preclude safe administration of a topical beta-adrenergic blocking agent.
  • History of spontaneous or current hypoglycemia or uncontrolled diabetes.
  • Known medical allergy, hypersensitivity, or poor tolerance to any component of Travacom deemed clinically significant in the opinion of the Principal Investigator.
  • Use of any additional topical or system ocular hypotensive medication during the study.
  • Participation in any other investigational study within 30 days prior to Screening visit.
  • Other protocol-defined exclusion criteria may apply.

Responsible Party: Alcon Research Identifier: NCT01510132     History of Changes
Other Study ID Numbers: C-11-012
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: October 18, 2012
Last Verified: October 2012

Keywords provided by Alcon Research:

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents