A Phase 4 interventional study of Travacom in Uncontrolled Intraocular Pressure, sponsored by Alcon Research. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-10.
Sponsored by Alcon Research · Phase 4, Interventional, and Treatment
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 mechanisms of action. The safety and efficacy of both travoprost and timolol have been established as single and adjunctive therapy in well-controlled clinical studies in thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The objective of this study is to assess the safety and efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension across India.
Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.
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Exclusion Criteria:
Travacom ophthalmic solution
Drug: Travacom
Travacom ophthalmic solution (1 drop per day)
Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only)
To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
Time frame: Baseline to Visit 3 (Week 6-8)
Safety: Adverse Events.
To assess the safety of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
Time frame: Baseline to Visit 3 (Week 6-8)
Secondary efficacy: Percentage of subjects at target IOP (</ 18 mmHg), regardless of prior therapy.
To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
Time frame: Baseline to Visit 3 (Week 6-8)
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Alcon Research