A Phase 3 interventional study of Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution and Travoprost 0.004%/Timolol 0.5% ophthalmic solution in Open-Angle Glaucoma and Ocular Hypertension, sponsored by Alcon Research. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.
Sponsored by Alcon Research · Phase 3, Interventional, and Treatment
The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).
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This study's enrollment of 301 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks
Drug: Travoprost 0.004%/Timolol 0.5% BAC-free ophthalmic solution
Travoprost 0.004%/Timolol 0.5% ophthalmic solution, 1 drop in each eye, once daily (QD) at 9 AM (±30 minutes), for 6 weeks
Drug: Travoprost 0.004%/Timolol 0.5% ophthalmic solution
Also known as: DuoTrav®
Mean Intraocular Pressure (IOP) combined across all visits and timepoints
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).
Time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)
Percentage of patients with IOP <18 mmHg or IOP percent reduction of ≥ 30% by visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg).
Time frame: Week 2 (9 AM, 11 AM, and 4 PM); Week 6 (9 AM, 11 AM, and 4 PM)
No study locations are listed for this record.
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Alcon Research