Travacom Post Marketing Surveillance Study

NCT ID: NCT01510132

Last Updated: 2012-10-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-01-31

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.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

OAG; OHT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Travoprost/timolol fixed combination (Travacom)

Intervention Type: DRUG

Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension

Interventions

Travoprost/timolol fixed combination (Travacom)

Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension

Intervention Type: DRUG

Other Intervention Names

Travacom

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Countries

United States

Other Identifiers

C-11-012

Identifier Type: -

Identifier Source: org_study_id