CLINICAL TRIALS PROFILE FOR TRAVOPROST

505(b)(2) Clinical Trials for TRAVOPROST

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NCT01452009 ↗	Three Month Safety and Efficacy Study of TRAVATAN® Versus Travoprost Ophthalmic Solution, 0.004%	Withdrawn	Alcon Research	Phase 3	2011-11-01	A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation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%
New Formulation	NCT01658839 ↗	Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients	Completed	Alcon Research	Phase 1	2013-01-01	The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.

All Clinical Trials for TRAVOPROST

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00051142 ↗	A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)	Completed	Alcon Research	Phase 3	2001-02-01	The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.
NCT00051181 ↗	A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma	Completed	Alcon Research	Phase 3	2000-01-01	To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.
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.
NCT00121147 ↗	Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan	Completed	Hermann Eye Center	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.
NCT00308945 ↗	Influence of Prostaglandins on Ocular Blood Flow in Glaucoma Patients	Completed	University Hospital, Basel, Switzerland	Phase 4	2003-11-01	Vasoactivity of topical drugs may be of prognostic relevance in glaucoma. There is very little information for a major class, the prostaglandin analogues with regard to this aspect. The purpose of this study is to compare the effect of travoprost 0.004% and latanoprost 0.005% on choroidal blood flow and retinal vascular diameter in glaucoma patients. After washout of current topical medication, intraocular pressure (IOP) in both eyes (Goldmann applanation tonometry), choroidal blood flow (laser Doppler flowmetry) and retinal vessel diameter (Retinal Vessel Analyzer) in one randomly selected eye will be measured at baseline, after two weeks and after 4 weeks of treatment with travoprost or latanoprost QD, in a randomized, double masked 2-way cross-over study in 20 open angle glaucoma patients.
NCT00331240 ↗	24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination	Completed	Aristotle University Of Thessaloniki	Phase 3	2006-03-01	The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular pressure control and safety of TravTim fixed combination given once in the evening with placebo once in the morning versus TravTim given once in the morning with placebo once in the evening in patients with open-angle glaucoma.

Clinical Trial Conditions for TRAVOPROST

Condition Name

Condition Name for TRAVOPROST
Intervention	Trials
Ocular Hypertension	61
Glaucoma	40
Open-Angle Glaucoma	23
Open Angle Glaucoma	11

Condition MeSH

Condition MeSH for TRAVOPROST
Intervention	Trials
Glaucoma	87
Ocular Hypertension	69
Glaucoma, Open-Angle	55
Hypertension	52

Clinical Trial Locations for TRAVOPROST

Trials by Country

Trials by Country for TRAVOPROST
Location	Trials
United States	122
Canada	6
Germany	3
Italy	3
Greece	3

Trials by US State

Trials by US State for TRAVOPROST
Location	Trials
Texas	19
California	10
Georgia	7
Ohio	6
Florida	6

Clinical Trial Progress for TRAVOPROST

Clinical Trial Phase

Clinical Trial Phase for TRAVOPROST
Clinical Trial Phase	Trials
Phase 4	56
Phase 3	19
Phase 2	13

Clinical Trial Status

Clinical Trial Status for TRAVOPROST
Clinical Trial Phase	Trials
Completed	78
Terminated	7
Active, not recruiting	5

Clinical Trial Sponsors for TRAVOPROST

Sponsor Name

Sponsor Name for TRAVOPROST
Sponsor	Trials
Alcon Research	57
Glaukos Corporation	7
Allergan	6

Sponsor Type

Sponsor Type for TRAVOPROST
Sponsor	Trials
Industry	85
Other	25
U.S. Fed	1