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Last Updated: November 18, 2019

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CLINICAL TRIALS PROFILE FOR TOBRADEX ST

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505(b)(2) Clinical Trials for Tobradex St

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New Formulation NCT00404937 Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle Withdrawn Alcon Research Phase 3 2006-12-01 The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
OTC NCT01560962 Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis Terminated Southern California Institute for Research and Education N/A 2012-01-01 Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Tobradex St

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00362895 A Bioequivalence Study of Tobradex AF Completed Alcon Research Phase 3 2006-04-01 The purpose of the study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
NCT00404937 Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle Withdrawn Alcon Research Phase 3 2006-12-01 The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation
NCT00447577 Zylet vs TobraDex in Blepharokeratoconjunctivitis Completed Bausch & Lomb Incorporated Phase 4 2007-01-01 The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis
NCT00473070 A Clinical Study of Tobradex AF Completed Alcon Research Phase 3 2006-11-01 The purpose of this study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.
NCT00532961 Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex Completed Bausch & Lomb Incorporated Phase 4 2005-02-01 Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.
NCT00576251 TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension Completed Alcon Research Phase 3 2007-10-01 The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
NCT00695435 Tobramycin Tear Concentrations Completed Alcon Research Phase 1 2008-06-01 To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tobradex St

Condition Name

Condition Name for Tobradex St
Intervention Trials
Cataract 6
Blepharitis 3
Blepharo Conjunctivitis 1
Inflammation 1
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Condition MeSH

Condition MeSH for Tobradex St
Intervention Trials
Cataract 7
Inflammation 4
Blepharitis 3
Conjunctivitis 3
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Clinical Trial Locations for Tobradex St

Trials by Country

Trials by Country for Tobradex St
Location Trials
Italy 35
United States 8
Greece 2
Brazil 2
Singapore 1
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Trials by US State

Trials by US State for Tobradex St
Location Trials
Texas 3
New York 1
California 1
Massachusetts 1
Pennsylvania 1
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Clinical Trial Progress for Tobradex St

Clinical Trial Phase

Clinical Trial Phase for Tobradex St
Clinical Trial Phase Trials
Phase 4 3
Phase 3 9
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Tobradex St
Clinical Trial Phase Trials
Completed 13
Unknown status 1
Not yet recruiting 1
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Clinical Trial Sponsors for Tobradex St

Sponsor Name

Sponsor Name for Tobradex St
Sponsor Trials
Alcon Research 6
Bausch & Lomb Incorporated 3
Veroia General Hospital 2
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Sponsor Type

Sponsor Type for Tobradex St
Sponsor Trials
Industry 13
Other 9
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