Topical naproxen sodium for inhibition of miosis during cataract surgery. Prospective, randomized clinical trials.

PURPOSE: To assess corneal penetration of naproxen sodium and its efficacy in maintaining intraoperative mydriasis during cataract surgery. METHODS: Two double blind studies have been performed comparing the efficacy of naproxen ophthalmic solution to that of placebo or diclofenac in inhibiting pre-operative miosis. Study No. 1 was a placebo-controlled study and involved 194 patients undergoing extracapsular cataract extraction. Study No. 2 was an active-controlled study (vs diclofenac) concerning 214 patients undergoing phacoemulsification. In both studies treatment started the day before surgery. A balanced salt solution containing adrenaline was used in all patients. Pupil size was measured prior to the corneal section and at the end of surgery. An aqueous humor sample was taken immediately before corneal incision in a subset of 20 patients to measure naproxen aqueous concentration. RESULTS: In both studies the pupillary diameter decreased during surgery within each treatment group in a statistically significant manner (P < 0.001). Naproxen was more effective than placebo (P < 0.01) and as effective as diclofenac in controlling pupil diameter regression during cataract. Mean concentration level of naproxen in the aqueous humor was 372.3 ng/ml. CONCLUSIONS: Naproxen sodium ophthalmic solution penetrates the cornea and it is effective in maintaining intraoperative mydriasis.

Topical netilmicin compared with tobramycin in the treatment of external ocular infection.

In a pilot double-blind, randomized, prospective controlled study the effectiveness and safety of 0.3% netilmicin ophthalmic solution were compared with those of 0.3% tobramycin in treating external bacterial ocular infections in 45 eligible patients. The treatment with both study medications resulted in a significant (p < 0.001, Wilcoxon test) reduction in the mean cumulative score of the signs and symptoms. However, no statistically significant differences were observed between the two groups. The clinical improvement rate was almost complete with either antibiotics. There was a statistically positive trend in the netilmicin group with regard to the microbiological improvement that was achieved in (87% of the netilmicin patients) compared with 77% of the tobramycin patients (77%). Antibiotic sensitivity revealed that 84% of the organisms isolated were sensitive to netilmicin whereas only 64% of them were sensitive to tobramycin. Only minor adverse events occurred in patients treated with either netilmicin or tobramycin. In conclusion, this study demonstrates that netilmicin is a promising new antibiotic for treating external ocular infections.

Safety and tolerability of naproxen ophthalmic solution in comparison to placebo.

BACKGROUND: Naproxen is a classic non-steroidal anti-inflammatory drug (NSAID) with established analgesic and anti-inflammatory potency. Its action is related to cyclooxygenase inhibition and consequent decrease in prostaglandin concentration in various fluids and tissues. Since prostaglandin release is involved in several ocular alterations, various NSAID eye drops have come into use in the clinical setting during the last decade. SUBJECTS, MATERIAL AND METHODS: A randomized, double-blind, placebo-controlled, three-way crossover design phase I was performed in 12 healthy volunteers to determine both tolerance and safety of a new NSAID ophthalmic solution containing sodium naproxen (0.1% and 0.2%). Both single dose and repeated dose (TID for 6 days) instillation were performed. Evaluation was entirely based upon tolerance criteria. Subjective and objective signs of ocular irritation and subject comfort preference were evaluated. Also medical examination, hematology, blood chemistry and urine analysis were also assessed to evaluate any possible effect of the test drugs and control. RESULTS: Neither ophthalmic tolerance parameters nor vital signs or laboratory parameters were influenced by treatments. A slight hyperemia of the conjunctiva was the only change observed in the eye during the study, whereas the only symptom mentioned was burning. CONCLUSION: It is concluded that both tolerability and safety of 0.1% and 0.2% naproxen solution are acceptable after single and repeated conjunctival administration.

Retinopathy of prematurity (ROP): optimal timing of clinical evaluation and standard procedures.

The authors present the protocol currently used in their institution for initial and follow-up evaluation of infants at high risk for developing retinopathy of prematurity (ROP). After topical anesthesia and lid speculum insertion, the examination is carried out using an indirect binocular ophthalmoscope with a +20 or +28-diopter lens. Mydriasis is achieved by instilling one drop of 1% tropicamide, followed by one drop of 0.5% tropicamide + 2.5% phenylephrine 15 minutes later and after an additional 15 minute interval, another drop of 1% tropicamide. If mydriasis is insufficient after one hour, one drop of a 0.5% tropicamide-5.0% phenylephrine solution may be instilled. The initial examination is performed between the third and fourth weeks of life. If any areas of retinal immaturity are found, the examination is repeated every other week and, later, every three to four weeks, until vascularization has reached the ora serrata. Should any sign of ROP be present during the first examination, the patient is examined weekly or every other week depending on the severity of clinical findings.