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

Alcon

Status and phase

Completed

Phase 4

Conditions

Uncontrolled Intraocular Pressure

Treatments

Drug: Travacom

Study type

Interventional

Funder types

Industry

Identifiers

NCT01159756

SMA-10-01

Details and patient eligibility

About

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.

Enrollment

468 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.