Efficacy and Toxicity Evaluation of Bepotastine Besilate 1.5% Preservative-Free Eye Drops Vs Olopatadine Hydrochloride 0.2% Bak-Preserved Eye Drops in Patients with Allergic Conjunctivitis

Abstract

Purpose

To study the efficacy and toxic effects of bepotastine besilate 1.5% preservative-free (BB-PF) and olopatadine 0.2% BAK-preserved (OL-BAK) drops on the ocular surface of patients with allergic conjunctivitis.

Patients and Methods

Ninety-seven patients with allergic conjunctivitis diagnosis participated in a prospective, multicenter, randomized, double-blind, controlled, parallel-group clinical trial. Patients received either BB-PF (n=48) or OL-BAK (n=49), both administered once daily in the morning. The patients were followed for 60 days. Ocular itching was the primary outcome measure. Secondary outcomes included ocular symptoms, signs, and non-ocular symptoms associated with rhinoconjunctivitis. Conjunctival impression cytology (CIC) was performed to evaluate histopathological changes related to the toxic effects of preservatives.

Results

BB-PF treatment was associated with a 1.30 more probability of diminished ocular itching than OL-BAK (odds ratio (OR)=1.30; 95% CI=(0.96–1.7); p=0.086). No statistically significant differences were found between treatments in the resolution of other ocular symptoms or signs, except for tearing, which was superior in the BB-PF (OR=1.37; 95% (1.26–1.47); p<0.0001). BB-PF was superior in terms of the resolution of rhinorrhea (p=0.040) and nasal itching (p=0.037). After 60 days of treatment, the BB-PF group exhibited 2.0 times higher probability of having a lower Nelson scale score compared to the OL-BAK group (OR=2.00; 95% CI=(1.19–3.34); p=0.010).

Conclusion

Both medications presented a similar efficacy in terms of the resolution of ocular signs and symptoms associated with ocular conjunctivitis. BB-PF is superior in the resolution of non-ocular symptoms and safer for the ocular surface than OL-BAK.

Keywords:

• allergic conjunctivitis
• bepotastine besilate
• olopatadine
• preservative-free
• ocular surface
• rhinoconjunctivitis

Abbreviations

AC, Allergic Conjunctivitis; AR, Allergic Rhinitis; BAK, Benzalkonium Chloride; BID, Twice a day; CAC, Conjunctival allergen challenge model; CIC, Conjunctival impression cytology; OSD, Ophthalmic Squeeze Dispenser; PF, Preservative-Free; TOSS, total ocular symptom scoring system.

Data Sharing Statement

Any data besides what is included in the manuscript will be shared. Data will be accessible from the corresponding author at any time.

Acknowledgments

We would like to acknowledge Dr Cintia Nashiro, Julieta Geraldi, Mercedes O’ Farrell, Pablo Bouzon, and Gonzalo Gordillo for their contribution to the recruitment and follow-up of patients.

Disclosure

Melina Sol del Papa and María Silvia Passerini are Poen Laboratories employees. Martin Berra, Fernanda Girado, and Alejandro Aguilar report on financial support provided by Poen Laboratories. Maria Cecilia Marini and Paula Albera report no conflicts of interest in this work.