Published: 2022-02-23

A comparative study on the pharmacovigilance scoring of causality assessment grading and staging of topical pharmacotherapy of ofloxacin 0.3% ophthalmic solution in bacterial conjunctivitis and ofloxacin 0.3% otic solution in otitis externa

Moumita Hazra


Background: Topical pharmacotherapeutic modalities would minimalize systemic adverse effects. Ofloxacin, the bactericidal racemic mixture, has inhibitory effects on DNA gyrase, DNA topoisomerase IV and IL-1α, IL-6, and IL-8. This was a comparative study for pharmacovigilance scoring of causality assessment grading and staging of topical ofloxacin pharmacotherapy in bacterial conjunctivitis and otitis externa.

Methods: Group A=50 bacterial conjunctivitis patients were prescribed topical ophthalmic 0.3% ofloxacin, 2 drops in each eye after every 3 hours for 2 days, and 2 drops in each eye after every 6 hours for next 5 days; and group B=50 otitis externa patients were prescribed topical otic 0.3% ofloxacin, 3 drops in each ear after every 6 hours for first 2 days, and 5 drops in each ear after every 12 hours for next 5 days. Comparative adverse drug reactions occurrence, like transient ocular burning or discomfort, ocular irritation, redness, stinging, pruritis, photophobia, ocular watering and dryness in group A, and pruritis, headache, dizziness, mild ear pain, rashes, and hypersensitivity reactions in group B, were analysed with adverse event case report forms, on days 0, 3, 5, 7, 10, 15, 30, and on follow-ups, with causality assessment scores, from adverse drug reactions grading and staging.

Results: The occurrence of adverse effects were statistically non-significant, in both groups, with causality assessment scoring for group A: -11, none on average=Unlikely causality, and group B: -11, none on average= Unlikely causality.

Conclusions: Topical ofloxacin therapy in group A and group B patients, were safe and tolerable; with nil causality of association of adverse drug reactions.



Pharmacovigilance, Pharmacovigilance causality assessment grading and staging scores, Fluoroquinolones, Ofloxacin, Bacterial conjunctivitis, Otitis externa, Topical pharmacotherapy

Full Text:



Bryskier A. Fluoroquinolones. In: Bryskier A ed. Antimicrobial agents: Antibacterials and antifungals. 1st ed. USA: ASM Press. 2005;668-788.

Mohammed HHH, Abuo-Rahma GEAA, Abbas SH, Abdelhafez EMN. Current trends and future directions of fluoroquinolones. Curr Med Chem. 2019;26(17):3132-49.

Hazra M. A multivariate comparative clinical pharmacotherapeutic efficacy and chronopharmacovigilance assessment study of ofloxacin, one of the commonplace TGFβ1 inducing and telomerase impairing fluoroquinolones, in treating acute gastroenteritis, chronic obstructive pulmonary disease, new drug-sensitive tuberculosis, recurrent mixed cutaneous infections, and post-surgical refractory wound infections, among the global patients, with heterogenous pharmacogeographic and pharmacogenomic constitution. Int J Basic Clin Pharmacol. 2021;10(3):270-80.

Karampela I, Dalamaga M. Could respiratory fluoroquinolones, levofloxacin and moxifloxacin, prove to be beneficial as an adjunct treatment in COVID-19? Arch Med Res. 2020;51(7):741-2.

Brar RK, Jyoti U, Patil RK, Patil HC. Fluoroquinolone antibiotics: an overview. Adesh Univ J Med Sci Res. 2020;2(1):26-30.

Tripathi KD. Sulfonamides, Cotrimoxazole and Quinolones. In: Tripathi M, ed. Essentials of Medical Pharmacology. 7th ed. New Delhi, London, Philadelphia, Panama: Jaypee Brothers Medical Publishers Ltd. 2013;708-715.

MacDougall C. Sulfonamides, Trimethoprim-Sulfamethoxazole, Quinolones, and Agents for Urinary Tract Infections. In: Brunton LB, Hilal-Dandan R, Knollmann BC, eds. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 13th ed. New York, Chicago, San Francisco, Athens, London, Madrid, Mexico City, Milan, New Delhi, Singapore, Sydney, Toronto: McGraw-Hill. 2018;1067-86.

Yadav V, Talwar P. Repositioning of fluoroquinolones from antibiotic to anti-cancer agents: an underestimated truth. Biomed Pharmacother. 2019;111:934-46.

World Health Organization. 2020. Differences among fluoroquinolones in the treatment of MDR-TB. World Health Organisation Archives. Available at: Accessed on 10 January 2021.

Azad HK, Assar S, Nosratabadi. A review of immunomodulatory effects of fluoroquinolones. Immunol Invest. 2020;1-20.

Karampela I, Dalamaga M. Could respiratory fluoroquinolones, levofloxacin and moxifloxacin, prove to be beneficial as an adjunct treatment in COVID-19? Arch Med Res. 2020;51(7):741-2.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.

WHO-UMC System for standardized case causality assessment. World Health Organisation (WHO)-Uppsala Monitoring Centre, 2013. Available at: Accessed 30 November 2021.

The United States Food and Drug Administration. Product monograph: Ofloxacin ophthalmic solution 0.3% antibacterial agent, 2016. Available at: Accessed 5 December 2021.

Schwab IR, Friedlaender M, McCulley J, Lichtenstein SJ, Moran CT. A phase III clinical trial of 0.5% levofloxacin ophthalmic solution versus 0.3% ofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis. Ophthalmology. 2003;110(3):457-65. Ofloxacin ear drops, 2020. Available at: Accessed 5 December 2021.

Ohyama M, Furut S, Ueno K, Katsuda K, Nabori T, Kiyota R et al. Ofloxacin otic solution in patients with otitis media: An analysis of drug concentrations. Arch Otolaryngol Head Neck Surg. 1999;125:337-40.