CLINICAL TRIALS PROFILE FOR TRAVATAN Z

505(b)(2) Clinical Trials for Travatan Z

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00670033 ↗	Travoprost New Formulations in Patients With Open-Angle Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 2	2008-04-01	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.
New Formulation	NCT01452009 ↗	Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%	Withdrawn	Alcon Research	Phase 3	2011-11-01	A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

All Clinical Trials for Travatan Z

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00047554 ↗	Study of TRAVATAN in Subjects With Iris Pigmentation Changes	Terminated	Alcon Research		2003-05-01	The purpose of this study was to monitor iris pigmentation changes over a 5-year period in patients with open-angle glaucoma or ocular hypertension. To be eligible for the study, these individuals must have experienced an iris pigmentation change while previously dosing with TRAVATAN.
NCT00051155 ↗	A 6-Week Safety and Efficacy Study of Travatan Compared to Xalcom in Subjects With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)	Completed	Alcon Research	Phase 3	2001-01-01	To compare the safety and IOP-lowering efficacy of TRAVATAN and XALCOM in subjects with open-angle glaucoma or ocular hypertension.
NCT00051168 ↗	A Long-term Safety Study of Once-daily Travatan	Completed	Alcon Research	Phase 3	2006-01-01	Long term safety study of TRAVATAN in patients with Open-angle glaucoma or ocular hypertension.
NCT00061503 ↗	Mechanism of Action of TRAVATAN 0.004% in Subjects With Glaucoma or Ocular Hypertension	Completed	Alcon Research	Phase 4	2003-04-01	The primary objective of this study is to describe the effect of TRAVATAN 0.004% Ophthalmic Solution on aqueous humor dynamics in subjects with a clinical diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
NCT00121147 ↗	Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan	Completed	Alcon Research	N/A	2003-09-01	The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.

Clinical Trial Conditions for Travatan Z

Condition Name

Condition Name for Travatan Z
Intervention	Trials
Ocular Hypertension	37
Glaucoma	22
Open-Angle Glaucoma	18
Open Angle Glaucoma	5

Condition MeSH

Condition MeSH for Travatan Z
Intervention	Trials
Glaucoma	52
Ocular Hypertension	39
Hypertension	32
Glaucoma, Open-Angle	31

Clinical Trial Locations for Travatan Z

Trials by Country

Trials by Country for Travatan Z
Location	Trials
United States	60
Canada	5
Belgium	1
Korea, Republic of	1
Portugal	1

Trials by US State

Trials by US State for Travatan Z
Location	Trials
Texas	8
Florida	4
California	4
Ohio	3
Pennsylvania	3

Clinical Trial Progress for Travatan Z

Clinical Trial Phase

Clinical Trial Phase for Travatan Z
Clinical Trial Phase	Trials
Phase 4	28
Phase 3	11
Phase 2	7

Clinical Trial Status

Clinical Trial Status for Travatan Z
Clinical Trial Phase	Trials
Completed	44
Terminated	6
Unknown status	1

Clinical Trial Sponsors for Travatan Z

Sponsor Name

Sponsor Name for Travatan Z
Sponsor	Trials
Alcon Research	36
Allergan	4
Pfizer	3

Sponsor Type

Sponsor Type for Travatan Z
Sponsor	Trials
Industry	48
Other	10
NIH	1