A randomized, double-maked, placebo-controlled, multicenter comparion of loteprednol etabonate ophthalmic upenion, 0.5%, and placebo for treatment of keratoconjunctiviti icca in patient with delayed tear clearance

Purpoe To evaluate loteprednol etabonate ophthalmic 0.5% upenion, veru placebo for treatment of the inflammatory component of keratoconjunctiviti icca in patient with delayed tear clearance. Deign Randomized, double-maked, placebo-controlled clinical trial. Method ixty-four patient with keratoconjunctiviti icca and delayed tear clearance were randomly aigned to receive either loteprednol or vehicle 4 time a day for 4 week. Patient were evaluated at week 2 and 4 of treatment and 2 week after treatment wa dicontinued. ymptom were cored uing a viual analog cale (VA) of 1 to 100. Corneal fluorecein taining wa cored 0 to 4 in five area. Conjunctival injection wa graded 0 to 3 in the inferior bulbar, naal bulbar, and inferior taral area. Lid margin injection wa graded 0 to 3. afety wa aeed by funducopy, len examination, biomicrocopy, viual acuity, and Goldmann tonometry, and by monitoring advere event and change in ymptom. Reult In ubet of patient with at leat moderate clinical inflammation, there wa a ignificant difference between the loteprednol-treated group and vehicle-treated group after 2 week of therapy. The difference did not reach tatitical ignificance at 4 week, although the loteprednol-treated patient retained their improvement compared with the vehicle-treated group. afety evaluation howed both treatment to be well tolerated and imilar in the frequency and type of advere event reported. Concluion The ue of topical loteprednol etabonate 0.5% 4 time a day may be beneficial in patient who have keratoconjunctiviti icca with at leat a moderate inflammatory component.