Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study

Nakatani, Hiroshi; Gomes, Paul J; Bradford, Ron; Guo, Qiang; Safyan, Eleonora; Hollander, David

doi:10.1080/09273948.2018.1432764

Cited by 10 publications

(7 citation statements)

References 21 publications

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“…Conjunctival irritation score Conjunctival hyperemia, chemosis, and ocular discharges were observed under a slit lamp [20]. Conjunctival hyperemia was scored as follows: 0 points: normal blood vessels; 1 point: vascular congestion is bright red; 2 points: vascular congestion is dark red, and blood vessels are difficult to distinguish; and 3 points: diffuse hyperemia is purple-red.…”

Section: Measurement Of Corneal Opacitymentioning

confidence: 99%

The artemisinin analog SM934 alleviates dry eye disease in rodent models by regulating TLR4/NF-κB/NLRP3 signaling

et al. 2020

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Dry eye disease (DED) is a multifactorial disorder of the tears and ocular surface characterized by manifestations of dryness and irritation. Although the pathogenesis is not fully illuminated, it is recognized that inflammation has a prominent role in the development and deterioration of DED. β-aminoarteether maleate (SM934) is a water-soluble artemisinin derivative with antiinflammatory and immunosuppressive activities. In this study, we established scopolamine hydrobromide (SCOP)-induced rodent model as well as benzalkonium chloride (BAC)-induced rat model to investigate the therapeutic potential of SM934 for DED. We showed that topical application of SM934 (0.1%, 0.5%) significantly increased tear secretion, maintained the number of conjunctival goblet cells, reduced corneal damage, and decreased the levels of inflammatory mediators (TNF-α, IL-6, IL-10, or IL-1β) in conjunctiva in SCOP-induced and BAC-induced DED models. Moreover, SM934 treatment reduced the accumulation of TLR4expressing macrophages in conjunctiva, and suppressed the expression of inflammasome components, i.e., myeloid differentiation factor88 (MyD88), Nod-like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein containing CARD (ASC), and cleaved caspase 1. In LPS-treated RAW 264.7 cells, we demonstrated that pretreatment with SM934 (10 μM) impeded the upregulation of TLR4 and downstream NF-κB/NLRP3 signaling proteins. Collectively, artemisinin analog SM934 exerts therapeutic benefits on DED by simultaneously reserving the structural integrity of ocular surface and preventing the corneal and conjunctival inflammation, suggested a further application of SM934 in ophthalmic therapy, especially for DED.

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Section: Measurement Of Corneal Opacitymentioning

confidence: 99%

The artemisinin analog SM934 alleviates dry eye disease in rodent models by regulating TLR4/NF-κB/NLRP3 signaling

et al. 2020

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“…Currently, oral/systemic antiallergics are inefficient at treating ocular symptoms of an allergic response20,21 and require hours for the onset of action 15. Cetirizine ophthalmic solution 0.24% demonstrated consistent superiority to vehicle for ocular itching in both studies, a rapid onset of action and a duration of action similar to other ophthalmic solutions 22–24. Thus, cetirizine ophthalmic solution 0.24% has the potential to quickly address the needs of a patient whose ocular symptoms are not being met by an oral therapeutic.…”

Section: Discussionmentioning

confidence: 67%

“…This model is an established method approved by regulatory agencies to determine therapeutic efficacy in the relief of allergic signs and symptoms. Numerous studies have demonstrated the clinical efficacy of therapeutics for the indication of allergic conjunctivitis using the CAC model including antihistamines, alcaftadine9 and olopatadine hydrochloride,10,11 and coritcosteroids such as Dextenza 12. Furthermore, bepotastine besilate ophthalmic solution was shown to be efficacious in the treatment of nasal symptoms using the CAC model,13 demonstrating a broad role for the CAC model in the development of allergic conjunctivitis therapeutics.…”

Section: Introductionmentioning

confidence: 99%

Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model

Meier

Torkildsen

Gomes

et al. 2018

OPTH

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PurposeThe purpose of these Phase III studies was to evaluate the efficacy and safety of cetirizine ophthalmic solution 0.24% compared with vehicle in the treatment of allergen-induced conjunctivitis using the Ora conjunctival allergen challenge (CAC)® model.MethodsThe single-center (Study 1) and multi-center (Study 2), double-masked, randomized, vehicle-controlled, parallel group, CAC studies were conducted over ~5 weeks and four study visits. The study design only differed in entry criteria: Study 2 required more severe allergic conjunctivitis symptoms. Subjects were screened for an allergen response at Visits 1 and 2 and then randomized at Visit 3. Approximately 100 subjects were randomized in each study. The primary efficacy endpoints were ocular itching and conjunctival redness 15 minutes and 8 hours post-treatment, post-CAC.ResultsCetirizine treatment administered 15 minutes or 8 hours prior to CAC resulted in significantly lower ocular itching at all time points post-CAC (P<0.0001) compared to vehicle in both studies. Conjunctival redness measured by the investigator was significantly lower after cetirizine treatment compared to vehicle at 7 minutes post-CAC at both 15 minutes and 8 hours post-treatment in both studies (P<0.05). All secondary endpoints were in favor and confirmatory of cetirizine efficacy with significant improvement in chemosis, eyelid swelling, tearing, ciliary redness, and episcleral redness, as well as nasal symptoms (rhinorrhea, nasal pruritus, ear or palatal pruritus, and nasal congestion) post-CAC. The most robust treatment differences were observed in Study 2 where more severe symptoms were required for study entry (P<0.05). No safety concerns for cetirizine ophthalmic solution 0.24% were identified.ConclusionCetirizine ophthalmic solution 0.24% was shown to be efficacious in the treatment of ocular and nasal signs and symptoms associated with allergic conjunctivitis and demonstrated a favorable safety profile. Clinical efficacy was demonstrated with a 15-minute onset of action and añ8-hour duration of action.

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“…6 Both actions prevent the effects of histamine on capillaries, thereby preventing histamine-induced pain and itching of mucous membranes. 7,8 In this work, HCl was selected due to its therapeutic potential reported in literature. 7,8 The developed formulation was characterized for various in vitro parameters such as swelling ratio, drug contents, and in vitro properties such as drug release and ocular irritation.…”

Section: Introductionmentioning

confidence: 99%

“…7,8 In this work, HCl was selected due to its therapeutic potential reported in literature. 7,8 The developed formulation was characterized for various in vitro parameters such as swelling ratio, drug contents, and in vitro properties such as drug release and ocular irritation. The ocular irritation of the formulation was evaluated to assess its potential as an ophthalmic drug delivery system.…”

Section: Introductionmentioning

confidence: 99%

Fabrication and evaluation of Olopatadine hydrochloride ocular inserts

Qureshi

Iqbal

Hussain

et al. 2020

Journal of Plastic Film & Sheeting

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Development of the novel delivery provides optimal drug delivery via facilitated transcorneal penetration and ultimately improved retention time in eye. The present study was to fabricate and evaluate the performance of ocular inserts of Olopatadine hydrochloride by consuming polymers such as hydroxypropyl methylcellulose, gelatin, and chitosan at various concentrations with different plasticizers using solvent casting technique. Prepared formulations were evaluated for thickness, weight variations, drug content, surface pH, swelling studies, and in vitro drug release. Fourier transform infrared spectroscopy studies showed that interaction occurred between polymer and drug, and successful drug entrapment occurred in the matrix. All formulations showed excellent film-forming capacity with good thickness and weight uniformity. Folding endurance proved that the inserts were soft, elastic, and flexible. Chitosan-based ocular inserts showed greater swelling index as compared to gelatin and hydroxypropyl methylcellulose inserts. In vitro studies showed prolonged drug release and followed zero-order kinetic model and non-Fickian drug release.

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Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study

Cited by 10 publications

References 21 publications

The artemisinin analog SM934 alleviates dry eye disease in rodent models by regulating TLR4/NF-κB/NLRP3 signaling

The artemisinin analog SM934 alleviates dry eye disease in rodent models by regulating TLR4/NF-κB/NLRP3 signaling

Phase III trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model

Fabrication and evaluation of Olopatadine hydrochloride ocular inserts

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