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

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.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Intraocular Pressure
• Intervention / Treatment: Drug: Travacom

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Kolkata, India, 700120
    • Disha Eye Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Travacom; Travacom ophthalmic solution	Drug: Travacom; Travacom ophthalmic solution (1 drop per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only)	To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.	Baseline to Visit 3 (Week 6-8)
Safety: Adverse Events.	To assess the safety of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.	Baseline to Visit 3 (Week 6-8)
Secondary efficacy: Percentage of subjects at target IOP (</ 18 mmHg), regardless of prior therapy.	To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.	Baseline to Visit 3 (Week 6-8)

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: July 8, 2010
• First Submitted That Met QC Criteria: July 8, 2010
• First Posted (Estimate): July 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 10, 2012
• Last Update Submitted That Met QC Criteria: April 7, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Glaucoma; Timolol; Travoprost; Travacom
• Other Study ID Numbers: SMA-10-01