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[Effectiveness and tolerance of a polyvidon substance in treatment of dry eye syndromes].

BACKGROUND
Insufficient wetting of the ocular surface is very frequent. Artificial tears are commonly used for therapy. The influence on symptoms and tolerability of a product formulated with polyvidon and electrolytes resembling natural tears were investigated.


METHOD
Efficacy and local tolerability of a polyvidon (polyvinylpyrrolidon) formulation in the treatment of the "dry-eye" syndrome were tested in an open multicenter study on 586 patients with dry-eye conditions of various etiology. Patients were treated under the conditions of daily usage with the tear substitutes Oculotect fluid or Oculotect fluid sine which are formulations with electrolytes in a composition which resembles natural tears. The duration of treatment was 8 weeks and application frequency was dependent on severity of dry-eye syndrome. The therapeutic effect was evaluated before treatment and after one, four and eight weeks by tear film break-up time (BUT test). Schirmer-I test and by ratings of patient's self assessment of their complaints. Additionally patients general and ophthalmological history was recorded.


RESULTS
Before the start of the treatment the BUT test and Schirmer-I test yielded mean values of 9.0 (+/-5.2) sec and 6.2 (+/-3.8) mm respectively. These values increased over the course of the approximately 8-week treatment period to 12.3 (+/-5.6) sec and 10.1 (+/-4.8) mm respectively. Both parameters increased as highly significant (p < or = 0.0001, Wilcoxon-Test). Before treatment patients rated the following complaints as medium strong or strong: sensation of foreign body (66%), burning (69%), sensation of pressure (48%) and/or conjunctival hyperemia (48%). Some 8 weeks later, only 5% (sensation of foreign body), 8% (burning), 5% (sensation of pressure) and 6% (conjunctival hyperemia) of the patients with all examination time points rated these complaints similarly. The efficacy and tolerability were rated by the ophthalmologist on visual analog scales (minimum 0, very poor to a maximum of 100, very good). The average efficacy rating was 72.9 (+/-21.5), Oculotect fluid and Oculotect fluid sine were rated practically identically. The tolerability was rated high at 81.6 (+/-17.6). Reports of undesirable side-effects were given by 15 patients (3%), none of these side-effects were serious.


CONCLUSIONS
In patients typically met in ophthalmologists' office, treatment with preserved or unpreserved artificial tear with polyvidone resulted in distinct improvement of their complaints.