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Last Updated: January 27, 2023

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New Formulation NCT00404937 ↗ Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle Withdrawn Alcon Research Phase 3 2006-12-01 The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation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
NCT00083551 ↗ UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy Completed Celgene Corporation Phase 3 1998-08-01 This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
NCT00083551 ↗ UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy Completed University of Arkansas Phase 3 1998-08-01 This study has been designed to evaluate whether "anti-angiogenesis" therapy with thalidomide and whether additional chemotherapy after transplant will be beneficial. Another objective is to find out what kinds of side effects occur with this combination of treatment and how often they occur.
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.
>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
Inflammation 1
Keratitis 1
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Condition MeSH

Condition MeSH for Tobradex St
Intervention Trials
Cataract 7
Inflammation 4
Conjunctivitis 3
Blepharitis 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 9
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
Arkansas 1
New York 1
California 1
Massachusetts 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 10
Phase 1 1
[disabled in preview] 5
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Clinical Trial Status

Clinical Trial Status for Tobradex St
Clinical Trial Phase Trials
Completed 15
Unknown status 2
Withdrawn 1
[disabled in preview] 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 15
Other 10
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