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

NCT ID: NCT01159756

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-11-30

Brief 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

Study Design

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

Study Groups

Travacom

Travacom ophthalmic solution

Group Type: EXPERIMENTAL

Travacom

Intervention Type: DRUG

Travacom ophthalmic solution (1 drop per day)

Interventions

Travacom

Travacom ophthalmic solution (1 drop per day)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
• Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
• Must be able to follow instructions and be willing and able to attend all study visits.

Exclusion Criteria

• A known medical history of allergy, hypersensitivity or poor tolerance to any component of Travacom that is deemed clinically significant in the opinion of the Principle Investigator.
• Any abnormality preventing reliable applanation tonometer in either eye. Corneal dystrophies.
• Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.

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

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Disha Eye Hospitals

Kolkata, , India

Countries

India

Other Identifiers

SMA-10-01

Identifier Type: -

Identifier Source: org_study_id