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CLINICAL TRIALS PROFILE FOR LATANOPROST

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505(b)(2) Clinical Trials for Latanoprost

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
OTC	NCT00402493	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Pfizer	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
OTC	NCT00402493	Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops	Completed	Philadelphia Eye Associates	N/A	2006-12-01	The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
New Formulation	NCT03331770	Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost	Completed	Laboratorios Poen	Phase 4	2017-01-06	This study evaluates the efficacy and tolerability of a new formulation of latanoprost without Benzalkonium Chloride (BAK-free). Patients with open-angle glaucoma who were using BAK-containing latanoprost ophthalmic solution for ≥6 months, switched to BAK-free latanoprost ophthalmic emulsion.

All Clinical Trials for Latanoprost

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.
NCT00140049	A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma	Completed	Pfizer	Phase 4	2005-07-01	To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
NCT00143208	Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.	Completed	Pfizer	Phase 4	2003-05-01	This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
NCT00159653	A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma	Completed	Pfizer	Phase 3	2005-07-01	To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
NCT00187577	Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata	Completed	University of California, San Francisco	N/A	2005-06-01	This is a single center, randomized, investigator-masked study to determine the efficacy and safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in patients who have lost their eyelashes due to alopecia areata. These medications are FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer, darker, and thicker eyelashes with their use. In this study, patients will be asked to apply these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped applicator once a day.

Clinical Trial Conditions for Latanoprost

Condition Name

Condition Name for Latanoprost
Intervention	Trials
Ocular Hypertension	95
Glaucoma	61
Open-Angle Glaucoma	23
Primary Open Angle Glaucoma	16

Condition MeSH

Condition MeSH for Latanoprost
Intervention	Trials
Glaucoma	132
Ocular Hypertension	113
Glaucoma, Open-Angle	93
Hypertension	88

Clinical Trial Locations for Latanoprost

Trials by Country

Trials by Country for Latanoprost
Location	Trials
United States	342
Italy	13
Canada	13
Greece	12
Japan	10

Trials by US State

Trials by US State for Latanoprost
Location	Trials
California	35
Texas	26
Georgia	22
New York	20
Florida	18

Clinical Trial Progress for Latanoprost

Clinical Trial Phase

Clinical Trial Phase for Latanoprost
Clinical Trial Phase	Trials
Phase 4	64
Phase 3	30
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Latanoprost
Clinical Trial Phase	Trials
Completed	109
Recruiting	22
Unknown status	15

Clinical Trial Sponsors for Latanoprost

Sponsor Name

Sponsor Name for Latanoprost
Sponsor	Trials
Pfizer	22
Alcon Research	13
Allergan	12

Sponsor Type

Sponsor Type for Latanoprost
Sponsor	Trials
Industry	118
Other	79
U.S. Fed	1