Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/1/2014 |
Start Date: | October 2012 |
End Date: | December 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-451-3937 |
Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination
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 patients with open-angle glaucoma or ocular hypertension with
uncontrolled intra-ocular pressure (IOP).
(Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom or Ganfort fixed combination
pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with
uncontrolled intra-ocular pressure (IOP).
Inclusion Criteria:
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion
glaucoma in both eyes.
- Be on a stable intra-ocular pressure-lowering regimen of prostaglandin fixed
combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.
- Intra-ocular pressure of between 19 and 35 mmHg at any time of day in at least one
eye.
- Have best corrected visual acuity 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 Criteria:
- 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 visual acuity 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.
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