A Comparison of Therapeutic Regimens Containing Moxifloxacin 0.5% Ophthalmic Solution and Gatifloxacin 0.3% Ophthalmic Solution for Surgical Prophylaxis in Patients Undergoing LASIK or LASEK
Durrie Vision, Overland Park, KS 66211, USA.Journal of Ocular Pharmacology and Therapeutics (Impact Factor: 1.47). 07/2005; 21(3):236-41. DOI: 10.1089/jop.2005.21.236
The purpose of these two studies was to compare the safety and tolerability of moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% ophthalmic solution for use with laser-assisted in situ keratomileusis (LASIK) and laser-assisted subepithelial keratomileusis (LASEK) patients. Treatment with the two antibiotic regimens was randomly assigned to fellow eyes of each patient. The LASIK study showed no difference between the two therapies in terms of visual acuity, pupil size, SPK, edema, haze, day- and nighttime glare, halos, clarity of day or night vision, and dry eye symptoms up to 1 week after surgery. Patients reported no preference between the two antibiotics on the basis of ease of use, irritation, redness, itching, gritty, sandy or scratchy feeling, speed of recovery, overall vision, or overall comfort up to 7 days after LASIK surgery. Corneal healing after LASEK surgery was equivalent for the antibiotic regimens containing moxifloxacin 0.5% ophthalmic solution and gatifloxacin 0.3% ophthalmic solution. When comparing safety and tolerability, these findings suggest an equivalent role for these fluoroquinolone antibiotics in surgical prophylaxis.
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ABSTRACT: To measure the achievable perioperative aqueous concentration of the commercially available topically administered fourth generation fluoroquinolones, moxifloxacin 0.5% ophthalmic solution, and gatifloxacin 0.3% ophthalmic solution, and to correlate this concentration with the agents' biological efficacy in the aqueous humor of patients undergoing routine cataract surgery. Prospective, randomized, parallel, double-masked, clinical trial. Fifty patients undergoing cataract extraction. Patients (n = 25) were given perioperative topical moxifloxacin 0.5% or topical gatifloxacin 0.3% (n = 25). One drop of antibiotic was administered every 10 minutes for 4 doses beginning 1 hour prior to surgery. Aqueous humor was sampled via paracentesis and antibiotic concentrations were determined using validated high performance liquid chromatography (HPLC) procedures. Dilution analyses were performed to determine the biological efficacy of the agents in the aqueous against Staphylococcus epidermidis, the most common cause of postcataract endophthalmitis. Aqueous humor antibiotic concentrations were measured using HPLC and microdilution bioassay techniques. Biological activity was measured as minimal inhibitory dilution and minimal bactericidal dilution. Aqueous humor concentrations for moxifloxacin via HPLC analysis were 1.80 (+/-1.21) microg/ml, whereas those for gatifloxacin were 0.48 (+/-0.34) microg/ml. This 3.8-fold difference in aqueous humor antibiotic concentrations was statistically significant (P = 0.00003). Similarly, the biological dilution analysis of the aqueous humor samples showed that moxifloxacin attained an estimated activity of 2.1 microg/ml, whereas the gatifloxacin activity was approximately 0.4 mug/ml, which represented a 4.9-fold difference. This study demonstrated that after topically administered perioperative antibiotics with cataract surgery, moxifloxacin 0.5% ophthalmic solution achieved a statistically significantly higher concentration in aqueous humor compared with gatifloxacin (P = 0.00003). Results from the broth dilution analysis showed that moxifloxacin 0.5% was biologically more active against S. epidermidis than gatifloxacin 0.3% in aqueous humor after topical application. There were no adverse events reported, and incision wounds healed quickly and as expected.
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ABSTRACT: Topical treatment of ocular bacterial infection is practiced widely, and the choice of the antibacterial agent depends on the nature of the infection, including the susceptibility of the organism, the tissue affected, and the safety profile of the agent. Moxifloxacin is a fourth-generation fluoroquinolone approved for ophthalmic use as moxifloxacin ophthalmic solution 0.5% (VIGAMOX, Alcon, Fort Worth, TX). Moxifloxacin ophthalmic solution 0.5% is self-preserved at a near-neutral pH of 6.8. In treating ocular infection, the three important aspects of therapeutic control are potency, penetration of the drug to the target site, and safety of the drug and the drug product. Moxifloxacin ophthalmic solution 0.5% provides antibacterial potency and high penetration of target ocular tissues. The ocular and systemic safety profile of moxifloxacin compares favorably with those of other fluoroquinolone antimicrobial agents, with a low risk of recognized quinolone-related toxicity. In vitro studies of fluoroquinolones with human or rabbit corneal epithelial cells or keratocytes suggest that moxifloxacin is similar in cytotoxicity potential to other drugs of this family. Specialized in vivo corneal wound-healing studies draw little distinction between moxifloxacin-treated eyes and those treated with other fluoroquinolones. Repeated-dose topical ocular studies in rabbits and monkeys, with high concentrations (up to 3%) of moxifloxacin and at treatment durations and regimens well in excess of label-prescribed use, demonstrated a high safety margin for ocular and extraocular tissues. Cornea, the tissue with highest exposure, was found to be unaffected by these high exposures, with slit-lamp biomicroscopy, corneal thickness measurement, intraocular pressure, and specular microscopy of the corneal endothelium (monkeys only), and histologic evaluation showing no effects, as compared with controls. Moxifloxacin ophthalmic solution 0.5% affords superior efficacy and ocular tissue penetration, with a favorable safety profile.
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ABSTRACT: This introduction provides an overview of the succeeding articles contained within this supplement on the new fourth-generation fluoroquinolone antibiotic product, moxifloxacin ophthalmic solution 0.5% (VIGAMOX, Alcon Laboratories, Inc., Fort Worth, TX). Moxifloxacin was developed specifically to address the increasing incidence of resistance to earlier-generation antibiotic molecules. Structural modifications to the moxifloxacin molecule have decreased the likelihood of the development of resistant organisms. This antibiotic has been shown to possess greater activity than previous-generation molecules against gram-positive bacteria while maintaining excellent potency against gram-negative organisms and nontuberculous (atypical) mycobacteria. Moxifloxacin ophthalmic solution 0.5% exhibits enhanced bioavailability due to a unique molecular structure that combines high lipophilicity for enhanced corneal penetration with high aqueous solubility at physiological pH. Numerous studies have shown that moxifloxacin ophthalmic solution 0.5% has high potency against a broad range of microbial species and a favorable profile in terms of safety and tolerability. The results presented in this supplement provide additional evidence for the potential benefits of moxifloxacin ophthalmic solution 0.5% in surgical prophylaxis and treatment of sight-threatening infections, such as bacterial conjunctivitis, endophthalmitis and keratitis.