CLINICAL TRIALS PROFILE FOR TOBRADEX

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New Formulation	NCT00404937 ↗	Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle	Withdrawn	Alcon Research	Phase 3	2006-12-01	The purpose of this study is to compare the new formulation of Tobradex to the current approved formulation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

All Clinical Trials for Tobradex

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

Condition Name

Condition Name for Tobradex
Intervention	Trials
Cataract	6
Blepharitis	3
Keratitis	1
Acute Bacterial Conjunctivitis	1

Condition MeSH

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

Clinical Trial Locations for Tobradex

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Tobradex

Clinical Trial Phase

Clinical Trial Phase for Tobradex
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	10
Phase 1	1

Clinical Trial Status

Clinical Trial Status for Tobradex
Clinical Trial Phase	Trials
Completed	15
Unknown status	2
Withdrawn	1

Clinical Trial Sponsors for Tobradex

Sponsor Name

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

Sponsor Type

Sponsor Type for Tobradex
Sponsor	Trials
Industry	15
Other	11

Tobradex: Clinical Trials, Market Analysis, and Projections

Introduction to Tobradex

Tobradex, a combination of tobramycin and dexamethasone, is a potent ophthalmic suspension used to treat various eye conditions, including bacterial infections and inflammatory ocular conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Efficacy and Safety

Clinical Trials Overview

Several clinical trials have been conducted to evaluate the efficacy and safety of Tobradex. One notable study was a multicenter, randomized, investigator-masked trial that compared Tobradex (tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05%) with azithromycin ophthalmic solution (1%) in treating moderate to severe blepharitis/blepharoconjunctivitis. The results showed that Tobradex provided faster inflammation relief and a statistically significant lower mean global score compared to azithromycin at Day 8, with no serious adverse events reported[1].

Another study aimed to compare the efficacy and safety of Tobradex ophthalmic suspension versus a generic tobramycin/dexamethasone suspension in treating blepharoconjunctivitis. This study focused on evaluating signs and symptoms during treatment and recording adverse effects[4].

Adverse Effects

While Tobradex is generally well-tolerated, reported adverse drug reactions include hypersensitivity and localized ocular toxicity, such as eye pain, eyelid pruritus, and eyelid edema[3].

Market Analysis

Current Market Size and Growth

The global Tobradex market, or more broadly the tobramycin eye drop market, has seen significant growth. As of 2023, the market was valued at approximately USD 0.90 billion and is projected to grow to USD 2.4 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 13% during the forecast period[2].

Another report indicates that the global tobramycin eye drop market was valued at USD 12.21 billion in 2023 and is expected to reach USD 19.05 billion by 2032, with a CAGR of 5.07% from 2024 to 2032[5].

Market Drivers

The increasing awareness and clinical evidence of the effectiveness of tobramycin eye drops are key drivers of the market. Randomized studies have consistently shown the clinical efficacy of tobramycin, particularly in treating bacterial infections and inflammatory ocular conditions. This has boosted the uptake of Tobradex and similar products[2].

Market Segmentation

The market is segmented by type (Tobramycin and Dexamethasone Ophthalmic Suspension, Tobramycin Ophthalmic Suspension, etc.), application (adult and children), end-users (hospitals, homecare, specialty clinics), and distribution channels (hospital pharmacy, online pharmacy, retail pharmacy). The adult segment is predicted to lead the segmental growth due to high demand from this demographic[2][5].

Regional Analysis

North America is expected to dominate the market due to increasing new product development initiatives, growing awareness of tobramycin eye drops, and an aging population. The region's advanced healthcare infrastructure and higher diagnostic rates also contribute to its market dominance[2][5].

Market Projections

Future Growth

The tobramycin eye drop market, including Tobradex, is anticipated to experience significant growth over the next decade. The projected CAGR of 13% from 2024 to 2031 and 5.07% from 2024 to 2032 indicates a robust market expansion driven by increasing demand for effective treatments for eye infections and inflammatory conditions[2][5].

Opportunities and Challenges

The growing incidence of eye infections, particularly among the aging population, presents a substantial opportunity for the market. However, factors such as the adverse effects of the product, increased production costs, and the scarce availability of raw materials could impede market growth[5].

Key Players and Generic Versions

Generic Approvals

Amneal Pharmaceuticals received FDA approval for a generic version of Tobradex in 2021, adding another complex ophthalmic product to their generics portfolio. This generic version, Dexamethasone and Tobramycin Ophthalmic Suspension 0.3%/0.1%, is indicated for steroid-responsive inflammatory ocular conditions and superficial bacterial ocular infections[3].

Market Competition

The market includes several key players, and the introduction of generic versions is expected to increase competition. However, the brand reputation and clinical efficacy of Tobradex are likely to maintain its market position[5].

Conclusion

Tobradex, with its combination of tobramycin and dexamethasone, remains a highly effective treatment for various eye conditions. Clinical trials have consistently demonstrated its efficacy and safety, driving its market growth. The global tobramycin eye drop market is poised for significant expansion, driven by increasing demand and clinical evidence.

Key Takeaways

• Clinical Efficacy: Tobradex provides faster inflammation relief compared to other treatments like azithromycin.
• Market Growth: The global tobramycin eye drop market is expected to grow significantly, with a CAGR of 13% from 2024 to 2031 and 5.07% from 2024 to 2032.
• Market Drivers: Increasing awareness of clinical effectiveness and growing incidence of eye infections are key drivers.
• Regional Dominance: North America is expected to dominate the market due to advanced healthcare infrastructure and an aging population.
• Generic Versions: The introduction of generic versions is expected to increase market competition.

FAQs

Q: What is Tobradex used for?

A: Tobradex is used to treat bacterial infections and inflammatory ocular conditions, including blepharitis and blepharoconjunctivitis.

Q: How does Tobradex compare to azithromycin in clinical trials?

A: Clinical trials have shown that Tobradex provides faster inflammation relief and a statistically significant lower mean global score compared to azithromycin in treating moderate to severe blepharitis/blepharoconjunctivitis[1].

Q: What are the potential adverse effects of Tobradex?

A: Reported adverse effects include hypersensitivity and localized ocular toxicity, such as eye pain, eyelid pruritus, and eyelid edema[3].

Q: What is the projected market size of the tobramycin eye drop market by 2031?

A: The market is projected to grow to USD 2.4 billion by 2031, with a CAGR of 13% from 2024 to 2031[2].

Q: Which region is expected to dominate the tobramycin eye drop market?

A: North America is expected to dominate the market due to increasing new product development initiatives, growing awareness, and an aging population[2][5].

Sources

1. Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution (1%) in the treatment of moderate to severe blepharitis/blepharoconjunctivitis. PubMed.
2. Global Tobramycin Eye Drop Market Size, Statistics & Overview By 2031. Data Bridge Market Research.
3. Amneal Receives Approval for Generic TobraDex. Amneal Pharmaceuticals.
4. To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin Dexamethasone Ophthalmic. ClinicalTrials.gov.
5. Tobramycin Eye Drop Market Size, Share, Analysis, Growth. Zion Market Research.