Multicenter clinical evaluation of bepotastine besilate ophthalmic solutions 1.0% and 1.5% to treat allergic conjunctivitis.
OBJECTIVE
To evaluate the effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo at reducing ocular itching and conjunctival hyperemia in the conjunctival allergen challenge (CAC) model of allergic conjunctivitis.


METHODS
Prospective, double-masked, randomized, placebo-controlled, phase 3 CAC clinical trial.


METHODS
This multicenter trial enrolled 130 subjects with a clinical history of allergic conjunctivitis who were randomized to bepotastine besilate ophthalmic solution 1.0%, 1.5%, or 0.0% (placebo). One drop of test agent was instilled bilaterally before a CAC test evaluating responses at 15 minutes, 8 hours, or 16 hours after test agent instillation. Primary efficacy outcomes were unit improvements relative to placebo in mean scores for ocular itching and conjunctival hyperemia, each graded on 0- to 4-unit scales.


RESULTS
Reductions of 1.2 units or more in mean ocular itching scores at all time points for both bepotastine besilate ophthalmic solutions 1.0% and 1.5% were observed at onset of action and 8-hour duration-of-action CAC tests (P < .0001). Statistically significant reductions in conjunctival hyperemia (P < or = .0125) were observed for bepotastine besilate ophthalmic formulations only at the onset of action CAC test.


CONCLUSIONS
Bepotastine besilate ophthalmic solutions 1.0% and 1.5% both substantially decreased CAC-induced ocular itching for at least 8 hours after dosing. Reductions in conjunctival hyperemia after a CAC, although statistically significant for bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo when assessed at 15 minutes after dosing, were modest.
Macejko
Thomas T
TT
Eye Care Associates of Greater Cincinnati, Inc, Fairfield, Ohio, USA.
Bergmann
Mark T
MT
Williams
Jon I
JI
Gow
James A
JA
Gomes
Paul J
PJ
McNamara
Timothy R
TR
Abelson
Mark B
MB
D000293:Adolescent; D000328:Adult; D018926:Anti-Allergic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003228:Conjunctiva / Q000098:blood supply; D003233:Conjunctivitis, Allergic / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006940:Hyperemia / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011725:Pyridines / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014792:Visual Acuity
D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D010880:Piperidines; D011725:Pyridines; C511534:bepotastine besilate