A Phase 2 interventional study of Travoprost ophthalmic solution (new formulation) and Travoprost ophthalmic solution, 0.004% in Ocular Hypertension and Open-angle Glaucoma, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-10.
Sponsored by Alcon Research (part of Alcon) · Phase 2, Interventional, and Treatment
The purpose of this study was to describe the safety and IOP-lowering efficacy of Travoprost New Formulations compared to TRAVATAN® and to vehicle in patients with open-angle glaucoma or ocular hypertension.
659 studies on the registry are indexed under Ocular Hypertension; 48 are open to participants now.
This study's enrollment of 158 is above the median of 118 across 517 interventional studies indexed under Ocular Hypertension.
Browse Ocular Hypertension studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.
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Exclusion Criteria:
Travoprost ophthalmic solution (new formulation), 1 of 3 dose levels, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Drug: Travoprost ophthalmic solution (new formulation)
Travoprost ophthalmic solution 0.004%, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Drug: Travoprost ophthalmic solution, 0.004%
Inactive ingredients, 1 drop in the study eye(s) once daily, at 8 PM, for 4 weeks
Drug: Vehicle
Also known as: TRAVATAN®, TRAVATAN Z®
Inactive ingredients used as a placebo
Mean change from baseline in intraocular pressure (IOP)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
Time frame: Baseline, Up to Week 4
Mean intraocular pressure
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time frame: Baseline, Up to Week 4
Mean percent change from baseline in IOP
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative percent change indicates a greater amount of improvement.
Time frame: Baseline, Up to Week 4
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Travoprost