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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01159756

First received: July 8, 2010

Last updated: April 7, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 8, 2010
Last Updated Date	April 7, 2012
Start Date ^ICMJE	July 2010
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 8, 2010)	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) ] [ Designated as safety issue: No ] To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension. Safety: Adverse Events. [ Time Frame: Baseline to Visit 3 (Week 6-8) ] [ Designated as safety issue: Yes ] To assess the safety of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension. Secondary efficacy: Percentage of subjects at target IOP (</ 18 mmHg), regardless of prior therapy. [ Time Frame: Baseline to Visit 3 (Week 6-8) ] [ Designated as safety issue: No ] To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01159756 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uncontrolled Intraocular Pressure
Intervention ^ICMJE	Drug: Travacom Travacom ophthalmic solution (1 drop per day)
Study Arm (s)	Experimental: Travacom Travacom ophthalmic solution Intervention: Drug: Travacom
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	468
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT01159756
Other Study ID Numbers ^ICMJE	SMA-10-01
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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