Travacom Post Marketing Surveillance Study
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|ClinicalTrials.gov Identifier: NCT01510132|
Recruitment Status : Withdrawn
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.
|Condition or disease||Intervention/treatment||Phase|
|Open-angle Glaucoma Ocular Hypertension||Drug: Travoprost/timolol fixed combination (Travacom)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Resource links provided by the National Library of Medicine
U.S. FDA Resources
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
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.
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