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

July 8, 2010
April 7, 2012
July 2010
November 2011   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01159756 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure
Not Provided

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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncontrolled Intraocular Pressure
Drug: Travacom
Travacom ophthalmic solution (1 drop per day)
Experimental: Travacom
Travacom ophthalmic solution
Intervention: Drug: Travacom
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
468
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01159756
SMA-10-01
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP