Clinical trial NCT01510132: Travacom Post Marketing Surveillance Study
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Open-angle Glaucoma
Ocular Hypertension
Keywords: OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older.
* Open-angle glaucoma or ocular hypertension insufficiently responsive to betablockers, prostaglandins, or other intraocular pressure-lowering (IOP) agents and when the use of Travacom is considered appropriate.
* Discontinued use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
* Mean IOP not greater than 36 mmHG in either eye.
* Read, sign, and date (or legal representative) the Informed Consent prior to the start of any study-related procedures.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Women of childbearing potential (not postmenopausal for at least one year or not surgically sterile) who are currently pregnant, have a positive result on the urine pregnancy test at Screening, intend to become pregnant during the study period, are breastfeeding, or do not agree to use an adequate birth control method to prevent pregnancy throughout the study.
* Chronic, recurrent, or severe inflammatory eye disease, such as scleritis, uveitis, or herpes keratitis.
* History of clinically significant or progressive retinal disease.
* Best corrected visual acuity (BCVA) score worse than 20/80 Snellen.
* Bronchial asthma or related history that would preclude safe administration of a topical beta-blocker.
* Severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease or related history that would preclude safe administration of a topical beta-adrenergic blocking agent.
* History of spontaneous or current hypoglycemia or uncontrolled diabetes.
* Known medical allergy, hypersensitivity, or poor tolerance to any component of Travacom deemed clinically significant in the opinion of the Principal Investigator.
* Use of any additional topical or system ocular hypotensive medication during the study.
* Participation in any other investigational study within 30 days prior to Screening visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Extent of exposure
timeFrame: Up to 8 weeks
measure: Adverse events
timeFrame: Up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: