Status:
TERMINATED
Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.
- On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
- IOP between 19 and 35 mmHg at any time of day in at least 1 eye.
- Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
- Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.
- Corneal dystrophies in either eye.
- Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.
- Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.
- Women who are pregnant or lactating.
- Participation in any other investigational study within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01514721
Start Date
June 1 2012
End Date
November 1 2013
Last Update
December 3 2014
Active Locations (1)
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1
Alcon Investigational Site
São Paulo, Brazil