Travacom Post Marketing Surveillance Study
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | July 2012 |
| End Date: | August 2013 |
| Contact: | Alcon Call Center |
| Phone: | 1-888-451-3937 |
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
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.
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.
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