MedTrace Logo

To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure

NCT01159756 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 468

Last updated 2012-04-10

No results posted yet for this study

Summary

This study is a multi-site, unmasked phase IV study. Travacom(R) is a combination topical ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by complementary mechanisms of action. The safety and efficacy of both travoprost and timolol have been established as single and adjunctive therapy in well-controlled clinical studies in thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The objective of this study is to assess the safety and efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension across India.

Conditions

  • Uncontrolled Intraocular Pressure

Interventions

DRUG

Travacom

Travacom ophthalmic solution (1 drop per day)

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01159756 on ClinicalTrials.gov