Safety and tolerability of naproxen ophthalmic solution in comparison to placebo

Background: Naproxen isa classic non-steroidal anti-inflammatory drug (NSAI D) with established analgesic and antiinflammatory potency. Its action is r elated to cyclooxygenase inhibition and consequent decrease in prostaglandi n concentration in various fluids and tissues. Since prostaglandin release is involved in several ocular alterations, various NSAID eye drops have com e into use in the clinical setting during the last decade. Subjects, materi al and methods: A randomized, double-blind, placebo-controlled, three-way c rossover design phase I was performed in 12 healthy volunteers to determine both tolerance and safety of a new NSAID ophthalmic solution containing so dium naproxen (0.1% and 0.2%). Both single dose and repeated dose (TID for 6 days) instillation were performed. Evaluation was entirely based upon tol erance criteria. Subjective and objective signs of ocular irritation and su bject comfort preference were evaluated. Also medical examination, hematolo gy, blood chemistry and urine analysis were also assessed to evaluate any p ossible effect of the test drugs and control. Results: Neither ophthalmic t olerance parameters nor vital signs or laboratory parameters were influence d by treatments. A slight hyperemia of the conjunctiva was the only change observed in the eye during the study, whereas the only symptom mentioned wa s burning. Conclusion: It is concluded that both tolerability and safety of 0.1% and 0.2% naproxen solution are acceptable after single and repeated c onjunctival administration.