The performance of an ophthalmic solution containing Poloxamer 407 and Polyquaternium 133 in reducing conjunctival bacterial load in patients receiving cataract surgery, a randomized trial

PurposeTo evaluate the safety and ability of an ophthalmic solution containing Poloxamer 407 and Polyquaternium 133 to reduce conjunctival bacterial load before cataract surgery.MethodsPatients (n = 74) were randomized to 2 groups: treatment (n = 37) or placebo (treatment's vehicle; (n = 37)) BID from V1 to V3. Patients were also given standard postoperative treatment from V2 to V3. Patients underwent ophthalmological examination, eye swabs, Break Up time (BUT), Ocular Surface Disease Index (OSDI), Oxford Scale and conjunctival hyperemia grading at V1 (day -3 from surgery), V2 (day 0, surgery), and V3 (day +7 from surgery). Overall subjective experience using the investigated ophthalmic solution and burning sensation were evaluated using Likert and VAS scales. Wilcoxon test, paired T-test and zero-inflated negative binomial models, were used when appropriate. A p ≤ 0,05 was considered significant. ClinicalTrials.gov identifier: NCT06533995.ResultsIntergroup analysis showed a significantly reduced bacterial load in treated comparing V2 vs V1 (p = 0,002) and V3 vs V1 (p = 0,0007). No differences were found in the controls. Zero-inflated negative binomial models were estimated: V2 Odds Ratio 0,44 (0,20; 0,98) p = 0,044, and V3 Odds Ratio 0,72 (0,12; 4,21) p = 0,71 in the treated. No significant differences between groups were found considering: BUT, OSDI, hyperemia, Oxford Score, subjective experience and burning.ConclusionsThe ophthalmic solution was tolerated and reduced, at all-time points, the bacterial load in the treated group. On the surgery day, the latter had a significantly reduced bacterial load than controls. Thus, suggesting the usefulness of the ophthalmic solution as an add-on therapy to reduce conjunctival bacterial load before cataract surgery.