Status:
COMPLETED
To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure
Lead Sponsor:
Alcon Research
Conditions:
Uncontrolled Intraocular Pressure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 mecha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT01159756
Start Date
July 1 2010
End Date
November 1 2011
Last Update
April 10 2012
Active Locations (1)
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1
Disha Eye Hospitals
Kolkata, India, 700120