78659
document
[ Effect on pressure after instillation of a drop of depot-pilocarpine . Clinical results of its medium-term action ] . 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 .
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Intervention_Pharmacological
depot-pilocarpine .
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Intervention_Pharmacological
new pilocarpine polymer ( Polym )
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Intervention_Pharmacological
traditional pilocarpine salt solution ( Plc )
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Intervention_Pharmacological
Polym
78664
Intervention_Pharmacological
Plc
78665
Intervention_Pharmacological
pilocarpine
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Intervention_Pharmacological
Plc
78667
Intervention_Pharmacological
pilocarpine
78668
Intervention_Pharmacological
Polym
78669
Intervention_Pharmacological
Polym
78670
Intervention_Pharmacological
Plc
78671
Intervention_Pharmacological
pilocarpine
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Intervention_Pharmacological
pilocarpine salt
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Intervention_Pharmacological
pilocarpine polymer
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Outcome_Physical
intraocular pressure ( IOP )
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Outcome_Other
prolonged therapeutic effect
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Outcome_Other
efficacity
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Outcome_Adverse-effects
adverse side effects
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Outcome_Physical
Visual disturbances
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Participant_Condition
40 open-angle patients treated with the long acting pilocarpine-complex for 120 days .