Natamycin 5% eye drops preservative free

Introduction Fungal corneal infection (fungal keratitis [FK]) poses significant treatment challenges. The efficacy of current topical antifungals is inconsistent and often limited, especially in low and middle-income countries where the majority of FK cases occur. Topical natamycin 5% is the current primary treatment in many countries, however, a substantial proportion of cases develop progressive disease, even with intensive treatment. Given the limitations of existing antifungal treatments, there is a need for alternative treatment strategies to address this condition. Chlorhexidine, an antiseptic with both antibacterial and antifungal properties, has received attention as a potential therapeutic agent. While a recent randomized controlled trial (RCT) in Nepal demonstrated the superiority of natamycin over chlorhexidine, a pilot study in Uganda has indicated a possible role for adjunctive chlorhexidine 0.2% in FK treatment. The contrasting findings necessitate a comprehensive RCT to investigate the potential benefit of adding topical chlorhexidine 0.2% alongside natamycin 5% in the management of FK. Methods We will test the hypothesis that topical natamycin 5% in combination with chlorhexidine 0.2% is superior to topical natamycin 5% alone in a two-arm, single-masked RCT (ISRCTN, ISRCTN87195453, registered 27/08/2020, https://www.isrctn.com/ISRCTN87195453 ). Participants are adults with FK presenting to tertiary ophthalmic hospitals in Tanzania and Uganda. Baseline assessment includes history, examination, photography, in vivo confocal microscopy and corneal scrapes for microbiology. Participants will be randomised to alternative topical antifungal treatments (topical chlorhexidine 0.2% and topical natamycin 5%; 1:1 ratio, 2-6 random block size). Patients will be reviewed at days 2, 7 (with re-culture), 14, 21, month 2, and month 3. The primary outcome is best spectacle corrected visual acuity (BSCVA) at three months. Primary analysis (intention-to-treat) will be by linear regression, with treatment arm and baseline BSCVA pre-specified covariates. Secondary outcomes include epithelial healing time, scar/infiltrate size, ulcer depth, hypopyon size, perforation and/or therapeutic penetrating keratoplasty, and positive re-culture rate.

Abstract licence: CC BY 4.0

Abstract Background: The study aimed to assess the efficacy and safety of Natamycin + Lactulose vaginal suppositories (100 mg natamycin and 300 mg lactulose) (AVVA RUS JSC, Russia) in adult females with vulvovaginal candidiasis. Methods and Results: An international, randomized, controlled, assessor-blinded clinical trial enrolled 218 females who were randomized into three groups: Natamycin + Lactulose (92 patients), Lactulose (36 patients), and Pimafucin® (90 patients). The study drug and comparator drugs had an identical dosing regimen (one suppository intravaginally once daily at bedtime for six days). The study involved four visits to the study site with the examination at Visits 2 and 3. Fixed combination of Natamycin + Lactulose was superior to both comparator drugs for the primary efficacy endpoint defined as percentage of patients who achieved a clinical recovery: the absence of symptoms of vulvovaginal candidiasis. At Visit 2, clinical recovery was reported in 81.6% of females in Natamycin + Lactulose group compared to 42.9% in Lactulose group and 62.3% of patients in Pimafucin group. The difference in proportions was 38.8% and 18.4%. In Natamycin + Lactulose group, microscopic recovery (Visit 2) was observed in 75.9% of patients at Visit 2 and in 90.8% of patients at Visit 3. In Lactulose group, 45.7% and 74.3% subjects responded positively at Visits 2 and 3. In Pimafucin group, 71.3% and 88.5% of patients showed microscopic recovery at Visits 2 and 3. For the microscopic recovery, no differences were reported between Natamycin + Lactulose and Pimafucin groups at both visits. At Visit 3, the number of vaginal lactobacilli was significantly higher in Natamycin + Lactulose group. In females with low baseline values of vaginal lactobacilli, the study combination increased the vaginal levels of lactobacilli to the reference values in 15.4% of patients at Visit 2, and in 20.9% of patients at Visit 3. Conclusions: The fixed combination Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories (AVVA RUS JSC, Russia) demonstrated superior efficacy compared to 1) Pimafucin 100 mg and 2) Lactulose 300 mg vaginal suppositories in adult females with vulvovaginal candidiasis. Trial registration: NCT06411314, retrospectively registered on May, the 13th, 2024.

Abstract licence: CC BY-NC-ND 4.0