Comparison of the Efficacy of Moxifloxacin Preparations in the Therapy of Conjunctivitis

Purpose. To evaluate the efficacy and safety of therapy in patients with bacterial conjunctivitis using Moxioftan^® eye drops, 5 mg/mL, 5 mL (JADRAN-GALENSKI LABORATORIJ, Croatia), and Vigamox^® eye drops, 5 mg/mL, 5 mL (Alcon Laboratories, Inc., USA).

Patients and methods. A multicenter, open-label, randomized, comparative clinical trial included 220 patients who were randomized into the Moxioftan^® (moxifloxacin) group (n = 110) as the main group or the Vigamox® (moxifloxacin) group (n = 110) as the control group. The primary efficacy endpoint was the frequency of clinical cure, defined as the disappearance of clinical signs of bacterial conjunctivitis at the final study visit (visit 5, day 9 ± 1). Secondary efficacy endpoints included the degree of bacterial eradication, defined as the absence of growth of the primary pathogen identified in the baseline conjunctival smear by day 9 ± 1, dynamics of clinical symptoms of bacterial conjunctivitis, treatment efficacy assessed by both investigators and patients. The safety evaluation included an assessment of the incidence of adverse events, serious adverse events, and their potential relationship to the investigational and comparator drugs. Statistical analysis was performed using the R statistical package v. 3.2.1 and Statistica 10.

Results. The clinical cure rate by day 9 ± 1 of the study (visit 5) was 100 % in both the main and control groups. The severity of clinical symptoms of bacterial conjunctivitis decreased equally in both groups by the final study visit: –5.32 ± 1.71 and –5.55 ± 1.40 points in the main and control groups, respectively (p > 0.05). By day 9 ± 1 of the study, the overall efficacy rating of “good” prevailed in both groups. According to patients, good efficacy was noted in 97.27 % and 94.55 % of cases in the main and control groups, respectively. According to investigators, good efficacy was observed in 96.36 % and 94.55 % of patients in the main and control groups, respectively. The safety analysis demonstrated a comparable safety profile for Moxioftan^® and Vigamox^®. The incidence and nature of adverse events were similar between the groups.

Conclusion: The study demonstrated comparable efficacy and a similar safety profile of Moxioftan^® eye drops compared to Vigamox^® in the treatment of patients with bacterial conjunctivitis.

1. Abduvakhobova M. Common ophthalmological diseases. Academic research in modern science. 2024;3(50):138–142 (In Russ.).

2. Hashmi MF, Gurnani B, Benson S. Conjunctivitis. [Updated 2024 Jan 26]. In: StatPearls Treasure Island (FL): StatPearls Publishing; 2025 Jan‑. Available from: URL:https://www.ncbi.nlm.nih.gov/books/NBK541034/

3. Ministry of Health of the Russian Federation. Clinical recommendations. Conjunctivitis. URL:https://cr.minzdrav.gov.ru/preview‑cr/629_2 (аccessed 27.01.2025) (In Russ.).

4. Azari AA, Arabi A. Conjunctivitis: A Systematic Review. J Ophthalmic Vis Res. 2020 Aug 6;15(3):372–395. doi: 10.18502/jovr.v15i3.7456

5. Prost M. Antibiotic therapy of bacterial conjunctivitis — a practical approach. Ophthatherapy. 2021;8(4):240–246. https://www.journalsmededu.pl/index.php/ophthatherapy/article/view/1728 (accessed 05.04.2025).

6. Chen YY, Liu SH, Nurmatov U, van Schayck OC, Kuo IC. Antibiotics versus placebo for acute bacterial conjunctivitis. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD001211. doi: 10.1002/14651858.CD001211.pub4.

7. Babushkin AE, Shevchuk NE. Bacterial conjunctivitis (literature review). The East– West viewpoint. 2021;3:87–90 (In Russ.).

8. Aramă V. Topical antibiotic therapy in eye infections — myths and certainties in the era of bacterial resistance to antibiotics. Rom J Ophthalmol. 2020;64(3):245–260.

9. Drago L. Topical Antibiotic Therapy in the Ocular Environment: The Benefits of Using Moxifloxacin Eyedrops. Microorganisms. 2024 Mar 25;12(4):649. doi: 10.3390/microorganisms12040649.

10. Wagner RS, Granet DB, Lichtenstein SJ, Jamison T, Dajcs JJ, Gross RD, Cockrum P. Kinetics of kill of bacterial conjunctivitis isolates with moxifloxacin, a fluoroquinolone, compared with the aminoglycosides tobramycin and gentamicin. Clin Ophthalmol. 2010 Feb 2;4:41–45. doi: 10.2147/opth.s9244.

11. Butylchenko O, Ermakov D, Babaskin D. Pharmacokinetic properties of Fluoroquinolones in Comparative Aspect of their effect on Pathogenic microflora. Research Journal of Pharmacy and Technology 2022;15(12):5800–5806. doi: 10.52711/0974360X.2022.00979.

12. Scoper SV. Review of third‑and fourth‑generation fluoroquinolones in ophthalmology: in‑vitro and in‑vivo efficacy. Adv Ther. 2008;25(10):979–994. doi: 10.1007/s12325‑008‑0107‑x.

13. Robertson SM, Curtis MA, Schlech BA, Rusinko A, Owen GR, Dembinska O, Liao J, Dahlin DC. Ocular pharmacokinetics of moxifloxacin after topical treatment of animals and humans. Surv Ophthalmol. 2005 Nov;50 Suppl 1:S32–45. doi: 10.1016/j.survophthal.2005.07.001.

14. Wagner RS, Abelson MB, Shapiro A, Torkildsen G. Evaluation of moxifloxacin, ciprofloxacin, gatifloxacin, ofloxacin, and levofloxacin concentrations in human conjunctival tissue. Arch Ophthalmol. 2005 Sep;123(9):1282–1283. doi: 10.1001/archopht.123.9.1282.

15. The leaflet is information for the patient. Moxiophtan®, 5 mg/ml, eye drops. URL:https://grls.minzdrav.gov.ru/Grls_View_v2.aspx?routingGuid=8709026faea3‑4e90‑9ed2‑c61e8f94b0c9 (accessed 05.04.2025) (In Russ.).

16. Gross RD, Schlech BA, Gower LA, Potts SL. Early clinical and microbiological responses in the treatment of bacterial conjunctivitis with moxifloxacin ophthalmic solution 0.5% (Vigamox™) using B.I.D. dosing. Today’s Therapeutic Trends. 2003;21:227–237.

17. Granet DB, Dorfman M, Stroman D, Cockrum P. A multicenter comparison of polymyxin B sulfate/trimethoprim ophthalmic solution and moxifloxacin in the speed of clinical efficacy for the treatment of bacterial conjunctivitis. J Pediatr Ophthalmol Strabismus. 2008 Nov‑Dec;45(6):340–349. doi: 10.3928/0191391320081101‑07.

18. Kodjikian L, Lafuma A, Khoshnood B, Laurendeau C, Berdeaux G. Efficacité de la moxifloxacine dans le traitement de la conjonctivite bactérienne aiguë : une méta‑analyse [Efficacy of moxifloxacin in treating bacterial conjunctivitis: a meta‑analysis]. J Fr Ophtalmol. 2010;33(4):227–233. French. doi: 10.1016/j.jfo.2010.02.001.

19. Keating GM. Moxifloxacin 0.5% ophthalmic solution: in bacterial conjunctivitis. Drugs. 2011 Jan 1;71(1):89–99. doi: 10.2165/11205840‑000000000‑00000.