Skip to main content
OpenTrials
Completed

NCT Number: NCT01159756

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uncontrolled Intraocular Pressure Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Disha Eye Hospitals

Kolkata, 700120, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Travacom

Drug

Travacom ophthalmic solution (1 drop per day)

Primary outcomes

  1. Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only)

    Time frame: Baseline to Visit 3 (Week 6-8)

    To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.

  2. Safety: Adverse Events.

    Time frame: Baseline to Visit 3 (Week 6-8)

    To assess the safety of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.

  3. Secondary efficacy: Percentage of subjects at target IOP (</ 18 mmHg), regardless of prior therapy.

    Time frame: Baseline to Visit 3 (Week 6-8)

    To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2010
Registry last updated
Apr 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.