Allan Rosenthal

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery:: A randomized, vehicle-controlled clinical trial

PURPOSE To investigate the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution (Acular; Allergan, Inc, Irvine, California) in the treatment of moderate to severe anterior segment inflammation developing after unilateral cataract surgery with intraocular lens implantation. METHODS Only patients who exhibited moderate or greater levels of cells and flare 1 day after surgery were included in this multicenter, double-masked, randomly assigned, parallel-group study. Topical ketorolac or vehicle solution (Allergan, Inc) was administered to the treated eye four times daily, starting the day after surgery and continuing for 14 days. RESULTS Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P < or = .030) and flare (P < or = .025), conjunctival erythema (P < or = .046), ciliary flush (P < or = .006), tearing (P < or = .012), photophobia (P < or = .014), and pain (P < or = .049). Half as many patients from the ketorolac group (14/51) were discontinued from the study for lack of efficacy, compared with the vehicle group (28/51; P = .005). There was no significant difference between ketorolac and the vehicle solution in changes in visual acuity, intraocular pressure, biomicroscopic or ophthalmoscopic variables, or adverse events. CONCLUSIONS Ketorolac tromethamine 0.5% ophthalmic solution is safe and provides substantial anti-inflammatory activity in the treatment of moderate to severe anterior segment inflammation developing after cataract surgery and intraocular lens implantation.

Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery

PURPOSE To compare the efficacy and safety of ketorolac 0.5% ophthalmic solution with its vehicle in the treatment of ocular inflammation after cataract surgery and intraocular lens implantation. DESIGN Multicenter clinical study. PARTICIPANTS One hundred four patients were prospectively randomized, 52 patients in treatment group, 52 patients in control group. METHODS Patients received either ketorolac or vehicle four times daily in the operated eye for 14 days starting the day after surgery in a prospective, double-masked, randomized, parallel group study. Only patients with moderate or greater postoperative inflammation the day after surgery were enrolled. MAIN OUTCOME MEASURES The main outcome measures include inflammation (cell, flare, ciliary flush), intraocular pressure and visual acuity. RESULTS Ketorolac was significantly more effective than vehicle in reducing the manifestations of postoperative ocular inflammation, including: anterior chamber cells (P: = 0.002) and flare (P: = 0.009), conjunctival erythema (P: = 0.010), ciliary flush (P: = 0.022), photophobia (P: = 0.027), and pain (P: = 0.043). Five times as many patients were dropped from the study for lack of efficacy from the vehicle group (22/52) than from the ketorolac group (4/52; P: = 0.001). Ketorolac was found to be equally as safe as vehicle in terms of adverse events, changes in visual acuity, intraocular pressure, and biomicroscopic and ophthalmoscopic variables. CONCLUSIONS Ketorolac tromethamine 0.5% ophthalmic solution was significantly more effective than vehicle in the treatment of moderate or greater ocular inflammation following routine cataract surgery, while being as safe as vehicle.

Topical tobramycin and gentamicin sulfate in the treatment of ocular infections: multicenter study.

Tobramycin is an aminoglycoside antibiotic newly marketed for topical ophthalmic use. In a double-masked, multicenter study, tobramycin and gentamicin sulfate, the latter an established topical aminoglycoside, were evaluated in the treatment of patients with bacterial infections of the external eye. Efficacy was determined by resolution of signs and symptoms and the follow-up impression made by the physician. A quantitative, bacterial assay of the conjunctiva and skin-lash margin before and after treatment was used to determine the antimicrobial effectiveness of the two antibiotics. The results of the study, involving 511 patients, indicate that tobramycin is significantly more effective than gentamicin sulfate clinically, and the former exhibits a greater antibacterial efficacy, in the eye, against the combined conjunctival pathogens. On the conjunctiva, Staphylococcus aureus is significantly more susceptible to tobramycin than gentamicin sulfate. Although the solutions are equally safe, tobramycin ointment is associated with a significantly lower frequency of adverse reactions than gentamicin sulfate ointment. This may be due to the preservative used in gentamicin ophthalmic ointment, methyl and propyl paraben.

Efficacy and safety profile of ketorolac 0.5% ophthalmic solution in the prevention of surgically induced miosis during cataract surgery

This multicenter, double-masked, randomized, parallel study compared the efficacy and safety profile of ketorolac tromethamine 0.5% ophthalmic solution with that of its vehicle in the maintenance of pupillary mydriasis during cataract surgery. A total of 176 adult patients scheduled to undergo unilateral extracapsular cataract extraction and posterior-chamber intraocular lens implantation received either ketorolac tromethamine 0.5% (n = 89) or vehicle (n = 87), starting 2 hours before surgery. One drop of study medication was instilled every 30 minutes for a total of 4 drops. No epinephrine was used in the intraoperative irrigating solution. Pupil diameter was measured with a caliper at 3 time points during surgery. To ensure participant safety, biomicroscopy, ophthalmoscopy, intraocular pressure, adverse events, and preoperative and postoperative visual acuity and refractive error were also monitored. The mean change in horizontal and vertical pupil diameter from the time of the first incision to after cortical irrigation and aspiration was significantly less with active ketorolac than with vehicle (P < or = 0.014). Consequently, mean pupil diameter after cortical irrigation and aspiration was significantly greater with ketorolac than with vehicle (P < or = 0.030). No significant between-group differences were observed in the change in pupil diameter between the end of surgery and postoperative administration of a miotic agent, safety variables, or occurrence of adverse events. In this study, ketorolac tromethamine 0.5% ophthalmic solution provided effective and well-tolerated inhibition of surgically induced miosis during cataract surgery.

Ocular pressure response to fluorometholone acetate and dexamethasone sodium phosphate

The intraocular pressure elevating potentials of fluorometholone acetate ophthalmic suspension and dexamethasone sodium phosphate ophthalmic solution were compared in human subjects who were previously documented to respond to dexamethasone sodium phosphate. In this double-masked, crossover study of 17 subjects, the same eye of each subject was dosed with both steroids, instillation of the second steroid following a one-month washout period. The length of time necessary to respond with an increase of 10 mmHg was ascertained. The mean response time for fluorometholone acetate was four weeks and for dexamethasone sodium phosphate, three weeks. This difference, in favor of fluorometholone acetate, is statistically significant.

A Clinical Comparison of Tobramycin and Gentamicin Sulfate in the Treatment of Ocular Infections

We evaluated the safety and efficacy of tobramycin and gentamicin sulfate ophthalmic solutions in the treatment of patients with bacterial infections of the conjunctivas. In this double-masked study involving 66 patients, the two aminoglycosides were found to be equally safe and effective, although the in vitro data suggested that tobramycin may be more efficacious against Pseudomonas infections. Staphylococcus aureus and S. epidermidis were the most frequent isolates from the infected eyes (59.8% and 20.6%, respectively).