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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
  Purpose

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.


Condition Intervention Phase
Uncontrolled Intraocular Pressure
 Drug: Travacom
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 468
Study Start Date: July 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Travacom
Travacom ophthalmic solution
 Drug: Travacom
Travacom ophthalmic solution (1 drop per day)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159756

Locations
India
Disha Eye Hospitals
Kolkata, India, 700120
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01159756     History of Changes
Other Study ID Numbers: SMA-10-01
Study First Received: July 8, 2010
Last Updated: April 7, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Alcon Research:
Travacom
Glaucoma
Travoprost
Timolol

ClinicalTrials.gov processed this record on May 19, 2013