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ORIGINAL RESEARCH

Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution: An 8-Weeks Phase III Study

ORCID Icon, , , , , & ORCID Icon show all
Pages 735-746 | Received 18 Nov 2022, Accepted 09 Feb 2023, Published online: 04 Mar 2023

Figures & data

Table 1 Baseline Characteristics of the Patients

Figure 1 Patient disposition (safety population).

Abbreviations: PAC, perennial allergic conjunctivitis; SAC, seasonal allergic conjunctivitis.
Figure 1 Patient disposition (safety population).

Table 2 Ocular TEAEs

Figure 2 Peak ocular discomfort and ocular tolerability for the bilastine and placebo groups at baseline (Week 0) and Week 8. Peak ocular discomfort was assessed for each eye on an integer scale of 0 to 10, where 0 represents no symptoms and 10 represents severe discomfort. Ocular symptoms were similarly rated on an integer scale of 0 to 10, where 0 represents no symptoms and 10 represents unbearable burning or stinging, excessive and continuous tearing or very severe blurring or stickiness. (A) Peak ocular discomfort; (B) burning; (C) stinging; (D) tearing; (E) blurring; (F) stickiness.

Figure 2 Peak ocular discomfort and ocular tolerability for the bilastine and placebo groups at baseline (Week 0) and Week 8. Peak ocular discomfort was assessed for each eye on an integer scale of 0 to 10, where 0 represents no symptoms and 10 represents severe discomfort. Ocular symptoms were similarly rated on an integer scale of 0 to 10, where 0 represents no symptoms and 10 represents unbearable burning or stinging, excessive and continuous tearing or very severe blurring or stickiness. (A) Peak ocular discomfort; (B) burning; (C) stinging; (D) tearing; (E) blurring; (F) stickiness.

Figure 3 Eye symptoms scores (TESS and ocular symptoms) at week 8. (A) Total population (Bilastine, N=194; Placebo, N=107); (B) PAC population (Bilastine, N=69; Placebo, N=40); (C) SAC population (Bilastine, N=125; Placebo, N=67). Error bars represent 95% confidence interval. A value of “10” presented maximum symptom severity and a value of “0” the absence of the respective symptom.

Abbreviations: PAC, perennial allergic conjunctivitis; SAC, seasonal allergic conjunctivitis; TESS, total eye symptom score.
Figure 3 Eye symptoms scores (TESS and ocular symptoms) at week 8. (A) Total population (Bilastine, N=194; Placebo, N=107); (B) PAC population (Bilastine, N=69; Placebo, N=40); (C) SAC population (Bilastine, N=125; Placebo, N=67). Error bars represent 95% confidence interval. A value of “10” presented maximum symptom severity and a value of “0” the absence of the respective symptom.