Travacom Post Marketing Surveillance Study
This study has been withdrawn prior to enrollment.
First Posted: January 13, 2012
Last Update Posted: October 18, 2012
Information provided by (Responsible Party):
The purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of Travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other intraocular pressure-lowering (IOP) medication and when use of Travacom is considered appropriate.
|Open-angle Glaucoma Ocular Hypertension||Drug: Travoprost/timolol fixed combination (Travacom)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Post Marketing Surveillance Study to Evaluate the Safety Profile of Travacom (Travoprost/Timolol Fixed Combination) in Patients With Open-Angle Glaucoma or Ocular Hypertension Across India|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Extent of exposure [ Time Frame: Up to 8 weeks ]Extent of exposure is calculated as days on therapy. Days on therapy is defined as the difference in days between the date of exit (last) instillation as recorded on the last visit and the visit at which medication was first administered.
- Adverse events [ Time Frame: Up to 8 weeks ]Any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. Adverse events will be collected spontaneously and systematically at each scheduled study visit and may be collected at any unscheduled visit that occurs during the study. Adverse events will be documented on Adverse Events Forms and will be reported by MedDRA preferred terminology.
|Study Start Date:||January 2012|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Travoprost/timolol fixed combination self-administered at the rate of 1 drop per eye, one time a day, at approximately 8 a.m. each day for 8 weeks.
Drug: Travoprost/timolol fixed combination (Travacom)
Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension
Other Name: Travacom
Contacts and Locations
No Contacts or Locations Provided