➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Boehringer Ingelheim
Baxter
Dow
Express Scripts

Last Updated: October 24, 2020

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR TOBRADEX

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

505(b)(2) Clinical Trials for Tobradex

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New Formulation NCT00404937 Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle Withdrawn Alcon Research Phase 3 2006-12-01 The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation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

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

Condition Name

Condition Name for Tobradex
Intervention Trials
Cataract 6
Blepharitis 3
Dry Eye 1
Post-surgical Inflammation 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Tobradex
Intervention Trials
Cataract 7
Inflammation 4
Conjunctivitis 3
Blepharitis 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Tobradex

Trials by Country

Trials by Country for Tobradex
Location Trials
Italy 35
United States 8
Brazil 2
Greece 2
Singapore 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Tobradex
Location Trials
Texas 3
New York 1
California 1
Massachusetts 1
Pennsylvania 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Tobradex

Clinical Trial Phase

Clinical Trial Phase for Tobradex
Clinical Trial Phase Trials
Phase 4 3
Phase 3 9
Phase 1 1
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Tobradex
Clinical Trial Phase Trials
Completed 13
Unknown status 1
Not yet recruiting 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Tobradex

Sponsor Name

Sponsor Name for Tobradex
Sponsor Trials
Alcon Research 6
Bausch & Lomb Incorporated 3
Veroia General Hospital 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Tobradex
Sponsor Trials
Industry 13
Other 9
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Moodys
AstraZeneca
Dow
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.