Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new tobradex research articles will be listed here shortly after becoming available to us.
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Medical research on tobradex
Curr Med Res Opin. 2008 Aug; 24(8): 2219-27
Bartlett JD, Holland EJ, Usner DW, Paterno MR, Comstock TL
OBJECTIVE: To compare the ocular comfort and tolerability of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; TobraDex) in healthy volunteers. RESEARCH DESIGN AND METHODS: In this multicenter, randomized, double-masked, parallel-group study, healthy volunteers (n = 306) were randomized to receive LE/T or DM/T four times per day for 28 days. Subjects recorded subjective ratings for seven comfort/tolerability parameters using an electronic patient diary (EPD). The primary endpoint was the difference at week 4 from the ratings of an artificial tear at baseline in comfort/tolerability parameters between treatment groups, using a noninferiority paradigm. CLINICAL TRIALS REGISTRATION: ClinicalTrials. gov, NCT 00532961. RESULTS: The 97.5% confidence intervals for the lower bound were within -10 for all of the seven comfort/ tolerability parameters evaluated (pain, stinging/burning, irritation, itchiness, foreign-body sensation, dryness, and light sensitivity). Secondary analysis revealed small but significant within-treatment differences in pain favoring LE/T over tears and in light sensitivity favoring tears over DM/T (p < 0.01). Small between-treatment differences in the changes from baseline tear ratings to individual study visits favored LE/T for pain, stinging/burning, irritation, itchiness, foreign-body sensation, and light sensitivity at visit 4 (p < or = 0.04); for pain, stinging/burning, and foreignbody sensation at visit 5 (p < or = 0.03), and for dryness and light sensitivity at visit 6 (p < or = 0.05). CONCLUSIONS: LE/T satisfied all conditions of noninferiority to DM/T in comfort and tolerability. Subjects receiving LE/T were more likely to report better ocular comfort/tolerability ratings relative to baseline artificial tears than subjects receiving DM/T. LIMITATIONS: The study population consisted of healthy volunteers.
Curr Med Res Opin. 2008 Jun; 24(6): 1569-75
McCormick C, Caballero A, Tang A, Balzli C, Song J, O'Callaghan R
OBJECTIVE: To quantitatively determine, in a Pseudomonas keratitis model, the anti-inflammatory and bactericidal properties of a new formulation of tobramycin (0.3%) and dexamethasone (0.05%) that utilizes a xanthan gum vehicle. RESEARCH METHODS: In a randomized and masked fashion, rabbit corneas (n>/=16 eyes per group) were intrastromally injected with 10(3) colony-forming units (CFU) of P. aeruginosa. Eyes were untreated or were administered a single drop every 15 min between 16 and 17 h postinfection (PI) and then a single drop every 30 min between 17 and 22 h PI, a total of 15 drops of either 0.1% dexamethasone and 0.3% tobramycin (TobraDex; Tdex) or a new formulation 0.3% tobramycin and 0.05% dexamethasone with xanthan gum (TobraDex ST; ST). Slit lamp examination scores (SLE+/-SEM) were derived from grading seven parameters at 22 h PI. Rabbits were sacrificed at 23 h PI and the log CFU+/-SEM per cornea was determined. RESULTS: Untreated eyes had SLE scores of 11.11+/-0.43 and had log CFU of 7.27+/-0.06. Eyes treated with Tdex, as compared to the untreated eyes, had significantly lower SLE scores (7.39+/-0.21, p
Adv Ther. 2008 Mar-Apr; 25(2): 77-88
Scoper SV, Kabat AG, Owen GR, Stroman DW, Kabra BP, Faulkner R, Kulshreshtha AK, Rusk C, Bell B, Jamison T, Bernal-Perez LF, Brooks AC, Nguyen VA
INTRODUCTION: TobraDex(R) ophthalmic suspension (tobramycin 0.3%, dexamethasone 0.1%; Alcon Laboratories Inc, Fort Worth, Tex) is frequently used for inflammatory ocular conditions where a risk of bacterial ocular infection exists. A new formulation, TobraDex(R) ST ophthalmic suspension (tobramycin 0.3%, dexamethasone 0.05%, Alcon), utilises a novel suspension technology to reduce viscosity and help prevent settling in the container. METHODS: A rabbit model that closely mimics the human eye and a clinical study with cataract patients was used to compare the pharmacokinetics and tissue permeability of TobraDex ST and TobraDex. An in-vitro model was used to assess the bactericidal activity using the rabbit tear concentrations of tobramycin 10 minutes after a single topical dose. RESULTS: Concentrations of both tobramycin and dexamethasone were greater in the tear film and ocular tissues of rabbits treated with TobraDex ST. There was an 8.3-fold increase in tobramycin concentration in the rabbit tear film 10 minutes after dosing with TobraDex ST compared with TobraDex. Concentrations of tobramycin and dexamethasone in ocular tissues from rabbits exposed to TobraDex ST were up to 12.5-fold greater relative to TobraDex. The in-vitro bactericidal activity (>99.9% kill, 3-log reduction) of TobraDex ST toward tobramycin-resistant and methicillin-resistant Staphylococcus aureus occurred in 90 minutes. TobraDex ST killed Streptococcus pneumoniae 3-log in 5 minutes. TobraDex had no activity toward tobramycin-resistant, methicillin-resistant S. aureus and required approximately 120 minutes for 3-log reduction of S. pneumoniae. In humans, the mean ratio of dexamethasone levels in the aqueous humour at 1 hour was 1.17 in favour of TobraDex ST. CONCLUSION: TobraDex ST demonstrated improved suspension formulation characteristics, enhanced pharmacokinetic distribution and improved bactericidal characteristics, and may provide a useful alternative as compared to TobraDex.
Curr Med Res Opin. 2008 Jan; 24(1): 287-96
White EM, Macy JI, Bateman KM, Comstock TL
OBJECTIVE: This study compared the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; Tobradex) in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis. Research design and methods: This was a multicenter, randomized, investigator-masked, parallel-group study. Subjects with clinically diagnosed blepharokeratocon-junctivitis in at least one eye were randomized to LE/T (n = 138) or DM/T (n = 138) administered four times per day, for 14 days. The primary efficacy endpoint was the change from baseline to Day 15 (+/- 1 day) in the signs and symptoms composite score using a non-inferiority metric to compare LE/T to DM/T. Safety endpoints included visual acuity (VA), biomicroscopy, intraocular pressure (IOP) assessments, and adverse events. RESULTS: At Day 15, the mean (SD) change from baseline in the signs and symptoms composite score was -15.2 (7.3) for LE/T-treated subjects and -15.6 (7.7) for DM/T-treated subjects. The upper bound of the 90% confidence interval for the difference in change from baseline was less than the non-inferiority margin not only at Day 15 but also at Day 7 and Day 3 for both the intent-to-treat and per protocol populations. Subjects treated with DM/T experienced a significant increase in IOP versus those treated with LE/T at Day 7, Day 15, and overall (mean [SD] of 0.6 [2.3] vs, -0.1 [2.2], p = 0.03, 1.0 [3.0] vs. -0.1 [2.4], p = 0.01, and 2.3 [2.3] vs. 1.6 [1.7], p = 0.02, respectively). CONCLUSIONS: LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an increase in IOP. Limitation: Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.
Adv Ther. 2007 Jan-Feb; 24(1): 60-7
Rhee SS, Mah FS
In this clinical trial, investigators compared the effectiveness of 2 commercially formulated antibiotic/steroid combinations - tobramycin 0.3%/dexamethasone 0.1% (Tobradex; Alcon, Fort Worth, Tex) and tobramycin 0.3%/loteprednol 0.5% (Zylet; Bausch & Lomb Inc., Rochester, NY) - for rapidly controlling inflammation in patients with blepharo-keratoconjunctivitis. Investigators in this randomized, parallel-group, double-masked study examined 40 eyes of 40 patients with blepharo-keratoconjunctivitis. Patients received tobramycin 0.3%/dexamethasone 0.1% or tobramycin 0.3%/loteprednol 0.5% twice daily in the test eye, according to the randomization schedule. At baseline, the ocular surface was graded on a scale of 3 (extensive) to 0 (minimum) for 4 components: blepharitis, conjunctivitis, ocular discharge, and corneal punctate epithelial keratopathy (PEK). Only those patients with moderate to extensive inflammation (cumulative score >6) were included in the study. At follow-up 3 to 5 d later, the ocular surface was regraded so that treatment response could be evaluated. No statistically significant difference was noted between groups in pretreatment scores for blepharitis (P=.31), discharge (P=.62), conjunctivitis (P=1.0), and PEK (P=.57), or for total ocular inflammation (P=.87). Mean posttreatment scores were as follows: total ocular surface scores, 1.8 and 3.4 (P=.002); blepharitis scores, 0.9 and 1.35 (P=.017); discharge scores, 0.2 and 0.6 (P=.025); and conjunctivitis scores, 0.15 and 0.6 (P=.013) for tobramycin/dexamethasone and tobramycin/loteprednol, respectively. Corneal PEK scores were not significantly different between treatments. Tobramycin 0.3%/dexamethasone 0.1% significantly decreased clinical signs of ocular inflammation (ie, blepharitis, discharge, conjunctivitis) and total ocular inflammation scores when compared with tobramycin 0.3%/loteprednol 0.5% in patients with moderate to severe blepharo-keratoconjunctivitis. The 2 regimens also provided comparably rapid decreases in corneal PEK.
Clin Drug Investig. 2004; 24(9): 523-33
Notivol R, Amin D, Whitling A, Wells D, Kennedy M, Cockrum PC,
OBJECTIVE: To demonstrate the superiority of TobraDex((R)) (tobramycin 3 mg/mL, dexamethasone 1 mg/mL) eye drops over Tobrex((R)) (tobramycin 3 mg/mL)/vehicle (placebo) eye drops in the prophylaxis of inflammation after cataract surgery, and to provide additional safety data on TobraDex((R)). SETTING: Twenty-two ophthalmology clinics from Brazil, Belgium, Germany, Ireland, Portugal, Spain and Sweden. PATIENTS AND METHODS: Prospective, randomised, double-masked, two-arm, parallel-group, placebo-controlled, multicentre study in 417 patients undergoing extracapsular cataract extraction with intraocular lens implantation. Patients were randomised (1 : 1) to TobraDex((R)) or to Tobrex((R))/vehicle. One drop of TobraDex((R)) or Tobrex((R)) was instilled in the operative eye (four times daily) on the day before surgery (day -1), one drop immediately following surgery in the operated eye (day 0), and then treatment (four times daily) was continued until day 7 (inclusive). From day 8 through day 21, patients in the TobraDex((R)) group continued with the same treatment, but patients in the Tobrex((R))/vehicle arm received the inactive ingredient only. Efficacy was assessed at 1, 3, 8, 14 and 21 days. The primary efficacy variable was the percentage of patients without post-surgical anterior chamber inflammation (i.e. with a sum of cells and flare scores of zero) on the day 8 visit. RESULTS: TobraDex((R)) was significantly better (p < 0.05) than Tobrex((R))/vehicle in controlling post-surgical inflammation at day 8 as shown by the percentage of patients with an inflammation score of zero (51% vs 21%, respectively). The percentage of patients with treatment failure was 4% vs 16% (p < 0.001) in favour of TobraDex((R)). In the safety population (n = 415), 19% of patients reported a total of 52 adverse events while receiving TobraDex((R)) and 35.3% patients reported 103 adverse events while receiving Tobrex((R))/vehicle. One patient receiving Tobrex((R))/vehicle discontinued the study due to an ocular allergic reaction. No patient experienced clinically relevant changes in visual acuity, fundus parameters, cup/disc ratio or intraocular pressure related to treatment following the day of surgery. CONCLUSIONS: TobraDex((R)) eye drops were superior to Tobrex((R))/vehicle in controlling post-surgical inflammation following cataract extraction. TobraDex((R)) administered four times daily over 21 days post-surgery was safe and well tolerated in patients treated for the prevention of post-surgical inflammation following cataract extraction.
[Clinical observation of tramadol on postoperative painment from LASEK]
Yan Ke Xue Bao. 2005 Dec; 21(4): 114-5, 123
Li Z, Wang P, Zhao R
PURPOSE: To evaluate the efficacy and safety of tramadol for controlling post-operative ocular pain from laser assisted subepithelial keratomileusis (LASEK). METHODS: A randomized and controlled study was used.Tramadol tablet is taken orally two times a day plus Tobradex and Diclofenac sodium eyedrops were administered four times a day to the study group and Tobradex and Diclofenac sodium eyedrops only were administered four times a day to the control group. Slitlamp biomicroscopy and clinical scoring (0 to 4) were used to assess pain, photophobia, tearing, stinging-burning (0 = no pain; 1 = mild pain; 2 = moderate pain; 3 = severes pain; 4 = very severe pain). The assessments were made at anterioroperation, 1 day, 4 days,7 days postoperatively. RESULTS: Post-operative pain cores for the study group and the control group were 0.48 +/- 0.67 and 1.70 +/- 0.69 (P < 0.001) at 1 day, 0.18 +/- 0.39 and 0.65 +/- 0.55 (P < 0.05) at 4 days, respectively. No severe complications were found in either group. CONCLUSION:tramadol plays an important role in efficacy and safety for controlling ocular pain and inflammation after LASEK.
Screening for drug-induced spoliation of the hydrogel optic of the AlphaCor artificial cornea.
Cont Lens Anterior Eye. 2006 May; 29(2): 93-100
Morrison DA, Gridneva Z, Chirila TV, Hicks CR
Clinical experience and in vitro investigations demonstrated that AlphaCor, a hydrogel keratoprosthesis, can undergo both surface spoliation and internal depositions/colourations after exposure to certain medications, alone or in combination. While the most commonly used medications have not been associated with spoliation in vivo, many medications are reportedly used due to the complex co-pathologies in many recipients, and regional variations in available medications. We screened a number of drugs used or proposed by surgeons for use in AlphaCor patients to evaluate their potential to cause visually significant optic spoliation (surface or intragel, or colour changes). Poly(2-hydroxyethyl methacrylate) discs with an identical composition to AlphaCor's optic were incubated with each medication and then with simulated aqueous humour (SAH) at 37 degrees C for 7 days. They were then examined under magnification and by histology (selected samples). Clinical feedback for the test medications was reviewed and compared with the in vitro results. A minority of the drugs caused surface spoliation (TobraDex, Prednefrin Forte, Azopt) or colour staining (including Zymar, Vigamox, Quixin) when tested alone, but SAH appeared to promote hydrogel cloudiness and surface deposits. The in vitro spoliation occurred more frequently than in vivo reports of spoliation in recipients of the same medications. This study is consistent with earlier findings in demonstrating involvement of topical medications in hydrogel spoliation, although a much lower incidence of spoliation is reported for AlphaCor in human recipients than indicated by the laboratory findings. The interactions of biological fluids and drugs require further study.
Eye. 2007 Jan; 21(1): 58-64
Russo S, Papa V, Di Bella A, Favero A, Radulescu C, Gafencu O, Carstocea B, Milazzo G
PURPOSE: The purpose of this study was to evaluate both efficacy and safety of a new ophthalmic steroid-antibiotic fixed combination containing dexamethasone and netilmicin in the postsurgical management of cataract surgery. METHODS: In total, 223 patients were randomly treated with dexamethasone 1 mg/ml plus netilmicin 3 mg/ml (n=148), or dexamethasone 1 mg/ml plus tobramycin 3 mg/ml (n=75, TOBRADEX) four times in a day for 7+/-1 days starting immediately after surgery. Efficacy (anterior chamber (AC) inflammation, conjunctival hyperaemia, corneal and lid oedema, ocular infection, pain, photophobia and tearing) and safety (burning, stinging, blurred vision, intraocular pressure, and visual acuity) were analysed in the operated eye after 1 and 7+/-1 days. A follow-up visit was performed at day 14+/-2. The extent of AC inflammation, measured by slit-lamp according to a standard scoring system, was used as primary efficacy parameter. RESULTS: At the primary end point (day 7) both fixed combinations were equally effective in reducing postoperative inflammation. The safety profile of the dexamethasone/netilmicin combination was excellent with no evidence of poor local tolerance or adverse reaction. CONCLUSIONS: A new fixed combination of dexamethasone and netilmicin was effective and safe in controlling ocular inflammation after cataract surgery.
Effect of corticosteroid-antibiotic agents on granulation tissue in a murine model.
Arch Otolaryngol Head Neck Surg. 2005 Apr; 131(4): 330-5
Sobol SE, Keswani S, Parvadia JK, Crombleholme T, Potsic WP
OBJECTIVE: To compare the effects of 3 commonly used ototopical corticosteroid-antibiotic agents, currently available for use in the treatment of inflammatory conditions of the external and middle ear, on granulation tissue in an established murine model of wound healing. SUBJECTS: Twelve C57/BL6J mice. DESIGN: Eight-millimeter wounds, created bilaterally on the dorsum of the mice, were treated with combinations of 0.3% ciprofloxacin and 0.1% dexamethasone (CiproDex), 0.3% tobramycin and 0.1% dexamethasone (TobraDex), 0.2% ciprofloxacin hydrochloride and 1% hydrocortisone (Cipro HC), or phosphate-buffered saline (n = 6 each) for 3 days (days 4-6) and then harvested on day 7. Wound sections were stained with hematoxylin-eosin, Gomori trichrome, and CD31. Extracellular matrix deposition was graded from 1-4, and neovascularization was assessed by counting the number of endothelial-lined vessel lumens per high-power field (HPF). RESULTS: The mean +/- SEM grade of extracellular matrix deposition was lower in CiproDex- (1.7 +/- 0.2) and TobraDex- (2.0 +/- 0.2) but not Cipro HC-(2.9 +/- 0.3) treated wounds compared with control wounds (2.9 +/- 0.2) (P