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M. Sacchetti, A. Lambiase, M. Cortes, R. Sgrulletta, S. Bonini, P. Aragona; Efficacy of Topical Treatment with Pranoprophene 0.1% in Allergic Rhinoconjunctivitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):3733.
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Purpose: To investigate the effect of Pranoprophene 0.1% (Pranoflog®-Sifi) eye-drops on ocular signs and symptoms and on the TNFα tear levels in 20 patients (40 eyes) with allergic rhinoconjunctivits. Methods: The diagnosis of allergic rhinoconjunctivitis was based on history, ophthalmic examination and positive response to a skin / RAST test. After a wash-out period of 7 days, the patients were evaluated at baseline for clinical signs (conjunctival hyperemia, chemosis and secretion, papillary reaction on superior tarsal conjunctiva), symptoms (itching, photophobia, burning, tearing and foreign body sensation) and tear fluid was collected. The clinical signs and symptoms were collected and scored from 0 to 3 (0= absent; 1= mild; 2= moderate; 3= severe). Topical treatment with Pranoprophene 0.1% was started three times a day for two weeks. After 15 days of treatment all patients were evaluated for signs and symptoms and tears were collected. TNFα levels were evaluated by a specific ELISA test. The Mann Whitney U test was used to compare signs, symptoms and TNFα tear levels at baseline vs 15 days of treatment. The Spearman Rho test was used to correlate TNFα levels to signs and symptoms at baseline and at 15 days. A p-value <0.05 was considered statistically significant. Results: After 15 days of Pranoprophene 0.1% treatment, a significant decrease of the total score of symptoms (p<0.0005) was observed and, in particular, itching, burning, and tearing resulted significantly decreased (p<0.05). After treatment, a significant decrease of the total score of signs (p<0.0005) was observed and, in particular, hyperemia, secretion and chemosis resulted significantly decreased (p<0.05). TNFα tear levels were not significantly reduced after 15 day of treatment and there was no significant correlation between TNFα levels and signs and symptoms at baseline and at 15 days. Conclusions: This open study should encourage further randomized and controlled clinical trials. Pranoprophene 0.1% eye drops may be considered an additional treatment for mild forms of ocular allergy.
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