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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR DEXAMETHASONE; TOBRAMYCIN

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Clinical Trials for Dexamethasone; Tobramycin

Trial ID Title Status Sponsor Phase Summary
NCT00447577 Zylet vs TobraDex in Blepharokeratoconjunctivitis Completed Bausch & Lomb Incorporated Phase 4 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
NCT00576251 TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension Completed Alcon Research Phase 3 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
NCT00669799 Topical Antibiotic Use In Chronic Rhinosinusitis A Double-Blinded, Randomized, Placebo Controlled Study Withdrawn University of South Florida N/A Chronic rhinosinusitis is a pervasive and costly disease. Recent estimates describe over 20 million Americans suffering from this diagnosis at a cost of over $4.3 billion per year. Primary intervention consists of oral antibiotics and nasal steroid sprays. A role for antifungal irrigation has also been proposed. Topical antibiotics are used by some physicians, but there are few reports in the published literature describing their use and establishing or refuting their efficacy. Sykes in 1986 performed a randomized, prospective, double-blinded study with 50 patients using topical nasal sprays with dexamethasone, tramazoline, and neomycin; dexamethasone and tramazoline without antimicrobial; and placebo. Both of the treatment groups showed improvement over placebo, but in those groups there was no significant difference in response rates between those patients receiving neomycin and those who did not. There were no adverse events reported. In the same year, Cuenant et al. reported success with neomycin-tixocortol irrigations in the treatment of chronic rhinosinusitis. Scheinberg and Otsuji and Vaughn and Carvalho describe their use of various nebulized antimicrobials (including aminoglycosides) in patients with recurrent sinusitis. Both are uncontrolled, retrospective studies showing improvement in symptom scores. Neither study reported any major side effects. Leonard and Bolger describe a case report and review their success with the use of topical Ceftazidime in 50 patients. Only one patient reported stinging sensation during administration. They reported no problems with antibiotic resistance. Studies by Davidson et al. , and Moss and King describe the use of topical antibiotics for sinusitis in patients with cystic fibrosis. They report improvement in sinusitis symptoms and reduction of need for revision sinus surgery in patients treated with surgery followed by topical intranasal tobramycin. They report no significant side effects. Dudley described the use of topical gentamicin in a case report of a patient with atrophic rhinitis. The patient had resolution of her complaints without any adverse symptoms. He also describes a study by Thornell showing success with streptomycin nasal sprays and reports work by Rubinstein demonstrating safe administration of gentamicin into the nose without absorption by the nasal mucosa. On balance, the literature describes topical antibiotics as a safe, but variably efficacious treatment for chronic rhinosinusitis. There is a paucity of prospective, randomized, blinded, and controlled studies. The purpose of this protocol is to describe a scientifically rigorous study of the use of broad spectrum antibiotic nasal sprays for chronic sinusitis. The patient population for this study will consist of patients who have a history of multiple sinus infections each year that require treatment with antibiotics. The patients in this study will have had recurrent infections despite prior medical and surgical intervention. They will fulfill the criteria for chronic rhinosinusitis without nasal polyposis. Treatment will include conventional treatment with oral antibiotics and a topical nasal steroid. In addition, patients will be randomized to receive either topical antibiotics or a vehicle placebo. The study will follow patients for a three month period. Patients will be monitored for improvement in radiographic findings and quality of life when compared to a randomized and double-blinded placebo group. The patient population identified for inclusion in this study will also be evaluated for allergy and humoral and innate immunodeficiency. Nasal lavage will be obtained from the study population and pre and post-treatment comparisons will be performed.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dexamethasone; Tobramycin

Condition Name

Condition Name for Dexamethasone; Tobramycin
Intervention Trials
Cataract 4
Rhinosinusitis 1
Blepharokeratoconjunctivitis 1
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Condition MeSH

Condition MeSH for Dexamethasone; Tobramycin
Intervention Trials
Cataract 5
Conjunctivitis 2
Conjunctivitis, Bacterial 1
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Clinical Trial Locations for Dexamethasone; Tobramycin

Trials by Country

Trials by Country for Dexamethasone; Tobramycin
Location Trials
United States 4
Greece 2
Brazil 1
Singapore 1
Italy 1
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Trials by US State

Trials by US State for Dexamethasone; Tobramycin
Location Trials
Texas 2
Florida 1
North Carolina 1
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Clinical Trial Progress for Dexamethasone; Tobramycin

Clinical Trial Phase

Clinical Trial Phase for Dexamethasone; Tobramycin
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Dexamethasone; Tobramycin
Clinical Trial Phase Trials
Completed 9
Withdrawn 1
Unknown status 1
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Clinical Trial Sponsors for Dexamethasone; Tobramycin

Sponsor Name

Sponsor Name for Dexamethasone; Tobramycin
Sponsor Trials
Veroia General Hospital 2
Alcon Research 2
Bausch & Lomb Incorporated 2
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Sponsor Type

Sponsor Type for Dexamethasone; Tobramycin
Sponsor Trials
Other 9
Industry 6
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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Express Scripts
Covington
Julphar
Argus Health
US Department of Justice
Baxter
Teva

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