[Clinical study of the effectiveness of a new preservative-free polyvidon preparation in therapy of dry-eye disorders].
BACKGROUND
Diseases of the ocular surface very frequently seen are related to irregularities of wetting. Patients often have complaints and feeling of ill-health, although under symptomatic therapy. Tolerability of the tear substitutes plays a key role in these cases. It is improved with unpreserved medication.


METHODS
59 patients with 'dry eye condition' of various etiology were enrolled in an open multicentre study and treated 8 weeks with a new preservative-free tear substitute. All patients had a history of previous ineffective treatment with artificial tears. The product was formulated with polyvidone and electrolytes in a composition which resembles natural tears. The therapeutic effect was evaluated by ratings of patients' self assessment of their complaints, tear film break up time (BUT), Schirmer I test, visual acuity, biomicroscopic examination and physicians' assessment.


RESULTS
Based on the key criteria patients's self assessment and BUT, the new agent (Oculotect fluid sine) improved symptoms and reduced discomfort significantly compared with the previous treatment (paired t test, two-sided, level of significance p < or = 0.05). The improved condition was confirmed by the other findings taken.


CONCLUSIONS
In 4/5 of patients, as typically met in ophthalmologists' offices, whose complaints were insufficiently relieved by previously applied tear substitutes, treatment with the new preservative-free product resulted in a distinct improvement of their condition. The lack of preservatives contributed to better tolerability and acceptance of tear substitution.
Mayer
H
H
Augenklinik der Medizinischen Hochscule Hannover.
Feuerhake
C
C
Joost
P
P
Sander
U
U
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015352:Dry Eye Syndromes / Q000209:etiology / Q000628:therapy*; D004573:Electrolytes / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011205:Povidone / Q000008:administration & dosage* / Q000009:adverse effects; D013666:Tears / Q000378:metabolism; D014792:Visual Acuity / Q000187:drug effects
D004573:Electrolytes; D009883:Ophthalmic Solutions; D011205:Povidone
Klinische Studie zur Wirksamkeit eines neuen unkonservierten Polyvidon-Präparats zur Therapie von Benetzungsstörungen.