15 completed, 3 terminated. 7 Phase 3, 4 Phase 1, 4 Phase 4, 3 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 7 | Completed 5, Terminated 2 |
| Phase 1 | 4 | Completed 4 |
| Phase 4 | 4 | Completed 4 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Not applicable | 1 | Completed 1 |
Follow besifloxacin: new trials by email Literature Review of besifloxacin trials Research Report on besifloxacin
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Swiss PACK-CXL Multicenter Trial for the Treatment of Infectious Keratitis PACK-CXL, Cefazolin in combination with either tobramycin or gentamicin, Cycloplegic agents (cyclopentolate 1% eye drops) - Keratitis; Infectious Disease (Manifestation) | Phase 3 | Completed | University Hospital, Geneva | 35 | 2016-03-01 | 2020-10-20 |
| Besifloxacin in Bacterial Keratitis Besifloxacin, Tobramycin and Cefazolin - Bacterial Keratitis | Not applicable | Completed | McGill University Health Centre/Research Institute of the McGill University Health Centre | 32 | 2015-09-01 | 2023-10-19 |
| A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers. Besivance 0.6% Ophthalmic Suspension, Zymaxid 0.5% Ophthalmic Solution, Vigamox 0.5% Ophthalmic Solution - Corneal Ulcers | Phase 2 | Terminated | Cornea Consultants Of Nashville | 2 | 2013-07-01 | 2015-08-13 |
| Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis Besifloxacin, Vehicle - Bacterial Conjunctivitis | Phase 3 | Terminated | Bausch & Lomb Incorporated | 136 | 2013-02-01 | 2014-10-01 |
| Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children Besivance Treatment Group, Polytrim Treatment Group - Congenital Nasolacrimal Duct Obstruction | Phase 1 | Completed | Rutgers, The State University of New Jersey | 24 | 2011-09-01 | 2016-07-14 |
| Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis Erythromycin, Besifloxocin - Blepharitis | Phase 4 | Completed | John, George, M.D. | 30 | 2011-08-01 | 2013-12-19 |
| Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis Besivance, Gatifloxacin - Bacterial Conjunctivitis | Phase 3 | Terminated | Bausch & Lomb Incorporated | 33 | 2011-05-01 | 2014-09-03 |
| Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification Moxifloxacin, besifloxacin - Cataracts | Phase 4 | Completed | Frank A. Bucci, Jr., M.D. | 120 | 2011-05-01 | 2020-12-22 |
| 2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery besivance, vigamox - Corneal Health, Cataract Surgery | Phase 4 | Completed | Ophthalmology Consultants, Ltd. | 60 | 2010-09-01 | 2011-10-19 |
| Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Besivance, Vehicle - Bacterial Conjunctivitis | Phase 3 | Completed | Bausch & Lomb Incorporated | 518 | 2010-06-01 | 2013-05-01 |
| Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis Besifloxacin, Vehicle (Placebo) - Bacterial Conjunctivitis | Phase 2 / Phase 3 | Completed | Bausch & Lomb Incorporated | 474 | 2009-10-01 | 2012-03-29 |
| Study of Ocular Penetration of Topically Administered Fluoroquinolones Moxifloxacin 0.5% ophthalmic solution, Besifloxacin 0.6% ophthalmic suspension - Cataract Extraction | Phase 4 | Completed | Johns Hopkins University | 50 | 2009-09-01 | 2017-10-24 |
| Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation Gatifloxacin, Moxifloxacin, Besifloxacin - Healthy | Phase 1 | Completed | Bausch & Lomb Incorporated | 119 | 2009-03-01 | 2011-12-09 |
| Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects Besifloxacin hydrochloride, moxifloxacin hydrochloride, gatifloxacin - Cataract Extraction | Phase 1 | Completed | Bausch & Lomb Incorporated | 105 | 2009-02-01 | 2011-12-13 |
| Systemic Pharmacokinetics of BOL-303224-A BOL-303224-A - Conjunctivitis, Bacterial | Phase 1 | Completed | Bausch & Lomb Incorporated | 24 | 2006-10-01 | 2011-12-09 |
| A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis. ISV-403, Vehicle - Acute Bacterial Conjunctivitis | Phase 3 | Completed | Bausch & Lomb Incorporated | 957 | 2006-06-01 | 2015-03-24 |
| A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis Besifloxacin, Moxifloxacin solution - Acute Bacterial Conjunctivitis | Phase 3 | Completed | Bausch & Lomb Incorporated | 1161 | 2006-06-01 | 2015-03-24 |
| Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis ISV-403, Vehicle - Bacterial Conjunctivitis | Phase 2 | Completed | Bausch & Lomb Incorporated | 270 | 2004-12-01 | 2015-03-24 |
Conjunctivitis, Bacterial (6) · Blepharitis (1) · Cataract (1) · Communicable Diseases (1) · Corneal Diseases (1) · Corneal Ulcer (1) · Eye Infections, Bacterial (1) · Keratitis (1)
Bausch & Lomb Incorporated (10) · Cornea Consultants Of Nashville (1) · Frank A. Bucci, Jr., M.D. (1) · John, George, M.D. (1) · Johns Hopkins University (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · Ophthalmology Consultants, Ltd. (1) · Rutgers, The State University of New Jersey (1) · University Hospital, Geneva (1)
United States (13) · Canada (1) · Switzerland (1)
Timothy Comstock, OD (3) · Johnson Varughese (2) · Catherine Allaire, MD (1) · Eric Donnefeld (1) · Farhad Hafezi, MD, PhD (1) · Frank A. Bucci, Jr., MD (1) · Ira A. Shivitz, M.D. (1) · Joseph Gira, MD (1) · Laura Trusso (1) · Michael R Paterno, OD (1) · Ranjan Maholtra, MD (1) · Suqin Guo, M.D. (1) · Walter J. Stark, M.D. (1)
PMID 20629472, PMID 32841261, PMID 19323612, PMID 19393842, PMID 21397770, PMID 22420526, PMID 22644963, PMID 32557558, PMID 34996516