Abstract
Purpose: To evaluate safety and tolerability on the ocular surface of an anti-septic formulation containing 0.6% povidone–iodine (0.6% PVI) for a 4 week period.Methods: An observational, prospective study included 20 mild-moderate dry eye disease (DED) patients who enrolled at the Ocular Surface Disease Unit of the University of Messina, receiving 0.6% PVI eye drops for 28 days, 2 drops twice daily (BID). The assessment included the Ocular Surface Disease Index questionnaire; symptoms score (0 = absent to 3 = severe) for burning, ocular dryness, foreign body sensation, watery eyes, tearing, photophobia, and ocular pain; fluorescein tear break-up time (TBUT); and corneal-conjunctival staining, performed at baseline (T0), after 7 (T7) and 28 (T28). Schirmer I-test, corneal endothelial cell count, intraocular pressure, and fundus examination were performed at T0 and T28. The main outcome measures were TBUT and corneal-conjunctival staining as markers of ocular surface homeostasis. For statistical analysis, Student's T-test and Wilcoxon test were used as appropriate.Results: No significant alterations of the safety parameters were found throughout the study. Further, at T28 a significant improvement of burning, ocular dryness, foreign body sensation, and watery eyes (T0 vs. T28 P < 0.03) were observed; corneal-conjunctival staining improved at T28 (T0 vs. T28 P < 0.0001), and TBUT improved already at T7 (T0 vs. T7 P = 0.0008) lasting so till the end of the study. The only adverse event was mild burning at instillation for the first 3 days of treatment in most of the patients.Conclusions: The treatment with 0.6% PVI was safe and well tolerated in a group of patients with a damaged ocular surface.
Highlights
An observational, prospective study included 20 mild-moderate dry eye disease (DED) patients who enrolled at the Ocular Surface Disease Unit of the University of Messina, receiving 0.6% PVI eye drops for 28 days, 2 drops twice daily (BID)
At the end of the treatment, all patients showed a significant improvement of the symptoms evaluated with the scoring system: In particular, statistically significant differences were observed for burning (P = 0.0002), ocular dryness (P = 0.0003), foreign body sensation (P = 0.0001), and watery eye (P = 0.03) at the T28 visit with respect to baseline values (Table 2)
The resistance to antibiotics is a worldwide growing emergence mostly derived by their inappropriate use; even their topical administration on the conjunctiva may induce changes of the ocular surface microbiota, reducing its diversity and promoting the proliferation of resistant
Summary
Povidone–iodine (PVI) is a commonly used antimicrobial agent, composed by a complex of hydrogen iodide, elemental iodine, and polyvynilpyrrolidone, a synthetic polymer.[1]The broad spectrum of antimicrobial activity and its efficacy, in relation to resistant micro-organisms, are well documented.[2]As a result of its broad spectrum of microbicide activity, 5% solution of PVI is routinely used in ophthalmic surgery for the prophylaxis against postsurgical endophthalmitis.[3,4,5]A novel ophthalmic eye drops formulation, in suspension, of 0.6% PVI, sodium hyaluronate (SH), and medium-chain triglycerides (MCT) nanoemulsion (0.6% PVI) was manufactured and available on the market.Basic science research showed that concentrations of PVI solutions
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