Andermann C, Mialhe D, Arne J L, Vende D, Bec P
J Fr Ophtalmol. 1983;6(4):367-74.
A clinical comparison of an emulsion containing a new pilocarpine polymer (Polym) compound to that of a traditional pilocarpine salt solution (Plc) on the intraocular pressure (IOP) has been performed in 40 open-angle patients treated with the long acting pilocarpine-complex for 120 days. The treatment protocol was divided into 3 stages: Stage 1 is a single dose treatment where 12 patients were divided randomly into 2 groups of 6 each. The patients of each group were given 1 drop into each eye: 1 drop every 12 hours for Polym, 1 drop every 6 hours for Plc. The patients were observed for a period of 24 hours. After 24 hours without medication, the treatments were crossed over and nycthemeral graph curves were registered for both groups. Stage 2 is a medium term study were the 12 patients used in Stage 1 were added to another 28 patients. All 40 were then assigned to 1 of 2 treatment groups (2 groups of 20 patients each) according to a table of random numbers. Treatments were administered during one month, then cross-overed again during 4 weeks. Stage 3: finally, every patient could choose his treatment (either Polym or Plc) for the rest of the period (2 months). The clinical study shows that the polymer complex (Polym) produced a prolonged therapeutic effect, this being consistant with a slow release pattern and maintained a more effective around-the-clock control than pilocarpine solution. These results were accomplished by two applications per day as compared to the four necessary applications of Plc, on a half daily pilocarpine dose with Polym. The medium term results confirmed the efficacity noted in the short term survey. Most patients preferred Polym to Plc when they were asked. Throughout the 4 months study period, no adverse side effects were reported. Visual disturbances characteristic of pilocarpine eye-drops were reduced from 3 times a day on pilocarpine salt solution to once a day on pilocarpine polymer complex.
