Multicenter Clinical Evaluation of Bepotastine Besilate Ophthalmic Solutions 1.0% and 1.5% to Treat Allergic Conjunctivitis

Macejko, T.T.; Bergmann, M; Williams, Jon I.; Gow, J.A.; Gomes, Paul J; McNamara, T.R.; Abelson, Mark B.

doi:10.1016/j.ajo.2010.02.007

Cited by 23 publications

(44 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…CAC is a method of inducing allergic conjunctivitis with itching and increased hyperaemia and oedema [15,16,17,18]. In most clinical studies of allergic conjunctivitis using CAC, the main parameters measured for the degree of conjunctivitis were the symptoms and signs observed by slit-lamp biomicroscopy.…”

Section: Discussionmentioning

confidence: 99%

“…The allergen solution and control solution were diluted with phosphate-buffered saline by 100-fold. In preliminary experiments, all subjects were tested to determine whether the allergen solution diluted by 100-fold caused symptoms and signs of allergic conjunctivitis in both eyes [15,16,17,18]. As expected, the instillation of the artificial tears and 0.025% levocabastine ophthalmic suspension without the allergen challenge did not lead to any signs or symptoms of allergic conjunctivitis.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of Allergic Conjunctivitis by Thermography

Hara

Shiraishi²,

Yamaguchi³

et al. 2014

Ophthalmic Res

View full text Add to dashboard Cite

Purpose: To evaluate ocular surface temperature in assessing the efficacy of anti-allergic eye drops. Methods: Thirteen asymptomatic patients (24.7 ± 2.8 years) with proven seasonal allergic conjunctivitis due to cedar pollen were studied. A 0.025% levocabastine ophthalmic suspension was instilled in one eye (levocabastine eye) and artificial tears in the other eye (artificial tear eye) in a masked fashion 10 min prior to a conjunctival allergen challenge (CAC). Then, a drop of cedar pollen solution was dropped into the conjunctival sac to induce the allergic reaction. The surface temperature of the inferior bulbar conjunctiva was measured before and 30 min after the CAC with a newly developed non-contact ocular surface thermographer (OST). The degree of conjunctival injection and chemosis was also determined by slit-lamp biomicroscopy. The changes in the symptoms were evaluated by a questionnaire. Results: After the CAC, the temperature increased by 0.67 ± 0.10°C in the artificial tear eyes but by only 0.21 ± 0.06°C in the levocabastine eyes (p < 0.05). The score for conjunctival injection was 1.38 ± 0.24 and the chemosis score was 0.85 ± 0.25 for the artificial tear eyes and 0.62 ± 0.27 and 0.08 ± 0.08 in the levocabastine eyes (p < 0.01). The temperature increase was significantly correlated with the conjunctival injection scores (r = 0.63; p < 0.001). Conclusion: The significant correlation of the conjunctival surface temperature with the severity of the conjunctival allergic reaction indicates that the temperature measured by the OST can be used to objectively evaluate the efficacy of topical anti-allergic agents.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Evaluation of Allergic Conjunctivitis by Thermography

Hara

Shiraishi²,

Yamaguchi³

et al. 2014

Ophthalmic Res

View full text Add to dashboard Cite

show abstract

“…37,38 pooled data from these two placebo-controlled, conjunctival allergen challenge (cac) trials that randomized 157 patients to receive either bepotastine (n=78) or placebo (n=79) were also analyzed. 39 Ocular itching, the primary efficacy measure, was significantly reduced in all patients receiving bepotastine compared with those receiving placebo (p<0.0001 for all time points).…”

Section: Mechanism Of Action Of Dual-acting Agents In Ocular Allergymentioning

confidence: 99%

Topical Corticosteroids and Antihistamines—Mast Cell Stabilizers for the Treatment of Allergic Conjunctivitis

Gong¹,

Blaiss²

2013

US Ophthalmic Review

View full text Add to dashboard Cite

ocular allergy is one of the most frequently encountered conditions in clinical eye care-epidemiologic reports have shown that it affects up to 60 million uS citizens. 1 The eye, being continually exposed to the external environment, is a common site of allergic inflammation. The classic clinical signs of this inflammation are seen in the conjunctiva. allergic conjunctivitis (ac) manifests as a immunoglobulin E (igE) hypersensitivity reaction that occurs when the ocular surface is exposed to external antigens. [2][3][4] These antigens include airborne pollen, animal dander, and other environmental antigens. 3,5 Even though these environmental antigens are not always threats to the ocular surface, they elicit an inappropriate adaptive immune response in some individuals, leading to this hypersensitivity reaction. Sac is most commonly caused due to exposure to pollens from grasses, trees, ragweed, or other seasonal plants. it therefore tends to occur frequently in spring and autumn, which are seasons associated with higher levels of these airborne allergens. 11 While the most obvious solution would be avoidance of the causative agents, this may not always be practical. The most commonly used nonpharmacologic interventions include cold compresses, lubrication, such as artificial tears, and the daily disposal of contact lenses in patients who are wearers. 12 Saline eye drops have been described as effective in reducing signs and symptoms in 30-35 % of cases. 13,14 AbstractThe most common ocular manifestation of allergy, allergic conjunctivitis (ac), is the result of a hypersensitivity response occurring after exposure of the ocular surface to airborne antigens. Treatment options for ac comprise antihistamines, mast cell stabilizers, dual-acting mast cell stabilizer-antihistamines, corticosteroids, nonsteroidal anti-inflammatory drugs (NSaids), and combinations thereof. despite clinical evidence to support the use of antihistamines, such as levocabastine, antihistamines are unable to mitigate all symptoms of ac because histamine is not the only mediator released during the allergic inflammatory response and has no direct effect on inflammatory cells involved in clinical symptoms. dual-acting mast cell stabilizer-antihistamines, such as bepotastine, alcafatidine, epinastine, ketotifen, and olopatadine, have a broader effect than antihistamines alone. corticosteroids inhibit the entire inflammatory cascade and therefore offer the most complete option for ac, although their use has been limited due to concerns about increased intraocular pressure (ioP) and the potential for cataract formation with extended use. loteprednol etabonate (lE) has a decreased effect on ioP and cannot form Schiff base intermediates with lens protein, which is considered a first step in cataractogenesis. The efficacy and safety of lE in the treatment of seasonal ac (Sac) has been demonstrated in clinical trials.

show abstract

“…Although the CAC methodology does not directly address the action of compounds as a mast cell stabilizer in human conjunctiva, the CAC has been validated by use in clinical trials with earlier generation ophthalmic agents that were subsequently approved by the U.S. Food and Drug Administration (FDA). [24][25][26][27][28] Positive results have been demonstrated in 2 well-controlled CAC clinical trials (one single site, one multisite) for the primary endpoints of ocular itching and conjunctival redness when assessed 15 min and 8 h after instillation of bepotastine besilate ophthalmic solutions, 22,23 and for the relief of nonocular allergic symptoms, including nasal congestion and rhinorrhea. 29 Those clinical trial results led to the approval of Bepreve Ò (bepotastine besilate ophthalmic solution) 1.5% in September 2009 by the FDA for the treatment of ocular itching associated with the signs and symptoms of allergic conjunctivitis.…”

Section: Introductionmentioning

confidence: 98%

“…21 Evaluation of the clinical effectiveness and safety of bepotastine besilate as an ophthalmic solution using the well-established conjunctival allergen challenge (CAC) clinical model of allergic conjunctivitis subsequently has been conducted. 22,23 As a result of positive outcomes in CAC trials and a favorable safety profile, bepotastine besilate ophthalmic solution 1.5% was recently approved in the United States for treating itching associated with the signs and symptoms of allergic conjunctivitis when dosed twice daily.…”

Section: Introductionmentioning

confidence: 99%