CLINICAL TRIALS PROFILE FOR TOBRADEX ST

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New Formulation	NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation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

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.

Clinical Trial Conditions for TOBRADEX ST

Condition Name

Condition Name for TOBRADEX ST
Intervention	Trials
Cataract	6
Blepharitis	3
Post-surgical Inflammation	1
Conjunctivitis	1

Condition MeSH

Condition MeSH for TOBRADEX ST
Intervention	Trials
Cataract	7
Inflammation	4
Conjunctivitis	3
Blepharitis	3

Clinical Trial Locations for TOBRADEX ST

Trials by Country

Trials by Country for TOBRADEX ST
Location	Trials
Italy	35
United States	9
Brazil	2
Greece	2
Taiwan	1

Trials by US State

Trials by US State for TOBRADEX ST
Location	Trials
Texas	3
New York	1
California	1
Massachusetts	1
Pennsylvania	1

Clinical Trial Progress for TOBRADEX ST

Clinical Trial Phase

Clinical Trial Phase for TOBRADEX ST
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	10

Clinical Trial Status

Clinical Trial Status for TOBRADEX ST
Clinical Trial Phase	Trials
Completed	16
Unknown status	2
Recruiting	1

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

Sponsor Type

Sponsor Type for TOBRADEX ST
Sponsor	Trials
Industry	15
Other	13

Last updated: May 4, 2026

TOBRADEX ST Clinical Trials Update, Market Analysis, and Projection

What is TOBRADEX ST and what product type is it?

TOBRADEX ST is an ophthalmic suspension containing tobramycin plus dexamethasone and is used for treating bacterial infections of the eye with associated inflammation, typically in conditions such as blepharitis/conjunctivitis with inflammation and post-operative inflammation with infection risk, depending on local labeling.
This assessment treats TOBRADEX ST as a branded, ophthalmic antibiotic-steroid combination in the U.S. prescription market.

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What do current public clinical trials show for TOBRADEX ST?

No complete, reliable, and properly citable public clinical-trials dataset was available in the provided context to produce an accurate, claim-ready “clinical trials update” for TOBRADEX ST specifically.
Given the constraint to deliver only complete and accurate hard data, the clinical-trials section below is not populated.

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TOBRADEX ST Market Analysis

How big is the ophthalmic antibiotic-steroid segment?

The ophthalmic market is large, with steroid-antibiotic combinations sitting in the subset used for infectious plus inflammatory ocular conditions and perioperative use. However, without a complete set of TOBRADEX ST-specific commercial data, the analysis below is limited to mechanics that can be supported without inventing numbers.

Market drivers for antibiotic-steroid ophthalmics

• Post-operative inflammation and infection-risk management in cataract and other ocular surgeries
• Chronic ocular surface disease flares where bacterial component plus inflammation affects symptoms and outcomes
• Physician preference and adherence to label-driven steroid tapering, where the dosing schedule and suspension characteristics matter

Market constraints

• Steroid-associated risks (intraocular pressure elevation, cataract progression, delayed healing) shift prescribing toward products with clear labeling, prescriber familiarity, and predictable response
• Generic erosion pressure on branded combinations as patents and exclusivities expire

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What competitive landscape matters most?

TOBRADEX ST competes within a crowded category that includes:

• Tobramycin + steroid branded or authorized equivalents
• Other antibiotic-steroid ophthalmic combinations (different antibiotic pairing, different steroid potency)
• Non-combination steroid or antibiotic products used as separate prescriptions when prescribers split therapy

The business impact usually comes from:

• formulation substitution (suspension vs gel vs ointment)
• tapering guidance and safety profile
• payer coverage and rebate structures
• access in retail chains and hospital formularies

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Projection Framework (What a valuation model would need)

What projection can be made from patent- and competition-typical patterns?

A numeric market projection cannot be generated from the provided context with sufficient evidentiary support.
Under a strict patent-analysis standard, any projection must be grounded in:

• product-level share or sales (or at minimum authoritative proxy)
• exposure drivers (prescriptions, diagnoses, perioperative volumes)
• pricing trajectory
• generic entry timing for the relevant combination
• patent and exclusivity status tied to the exact labeled formulation and brand

No such product-specific dataset is present in the input, so a defendable projection cannot be produced without fabricating.

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Key Takeaways

• TOBRADEX ST is an ophthalmic tobramycin + dexamethasone antibiotic-steroid suspension used for infectious ocular conditions with inflammation.
• A clinical trials update specific to TOBRADEX ST is not deliverable from the provided context with the required level of evidentiary completeness.
• A numeric market analysis and projection for TOBRADEX ST cannot be produced without product-level and category-level inputs tied to authoritative sources.

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FAQs

1) What drug is TOBRADEX ST?

TOBRADEX ST is an ophthalmic suspension containing tobramycin and dexamethasone.

2) What is its therapeutic use?

It is used to treat bacterial eye infections with associated inflammation, with exact indications depending on local labeling.

3) Are there active clinical trials for TOBRADEX ST right now?

A TOBRADEX ST-specific, evidence-based trials update is not possible from the provided context.

4) What drives demand for antibiotic-steroid eye drops?

Surgical and clinical management of ocular inflammation with infection risk and diagnosis-driven prescribing.

5) What are the key commercial risks?

Steroid safety considerations and generic or alternative combination substitution that can pressure branded pricing and share.

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References (APA)

[1] No citable sources were provided in the input content.