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  1. Artikel ; Online: Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease.

    Hauswirth, Scott G / Kabat, Alan G / Hemphill, Mandy / Somaiya, Karan / Hendrix, Laura H / Gibson, Andrea A

    Journal of comparative effectiveness research

    2023  Band 12, Heft 6, Seite(n) e220215

    Abstract: Aim: ...

    Abstract Aim:
    Mesh-Begriff(e) Humans ; Nasal Sprays ; Varenicline/therapeutic use ; Ophthalmic Solutions/therapeutic use ; Dry Eye Syndromes/drug therapy ; Dry Eye Syndromes/chemically induced ; Cyclosporine/therapeutic use ; Treatment Outcome
    Chemische Substanzen lifitegrast (038E5L962W) ; Nasal Sprays ; Varenicline (W6HS99O8ZO) ; Ophthalmic Solutions ; Cyclosporine (83HN0GTJ6D)
    Sprache Englisch
    Erscheinungsdatum 2023-04-25
    Erscheinungsland England
    Dokumenttyp Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2669725-7
    ISSN 2042-6313 ; 2042-6305
    ISSN (online) 2042-6313
    ISSN 2042-6305
    DOI 10.57264/cer-2022-0215
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel: Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials.

    Nijm, Lisa M / Zhu, Dagny / Hemphill, Mandy / Blemker, Gretchen L / Hendrix, Laura H / Kabat, Alan G / Gibson, Andrea A

    Ophthalmology and therapy

    2022  

    Abstract: Introduction: This study sought to compare the efficacy of OC-01 (varenicline solution) nasal spray for treatment of dry eye disease (DED) in postmenopausal women (PM+) versus women who were not postmenopausal (PM-).: Methods: This was a post hoc ... ...

    Abstract Introduction: This study sought to compare the efficacy of OC-01 (varenicline solution) nasal spray for treatment of dry eye disease (DED) in postmenopausal women (PM+) versus women who were not postmenopausal (PM-).
    Methods: This was a post hoc subgroup analysis of data integrated from two prior randomized controlled clinical trials, ONSET-1 and ONSET-2. Women randomized to treatment with OC-01 (varenicline solution) nasal spray 0.03 mg or vehicle control (VC) whose self-reported menopausal status (PM+ versus PM-) was known were included. Outcomes included the treatment difference (the OC-01 [varenicline solution] nasal spray change from baseline [CFB] minus VC CFB) in Schirmer test score (STS, mm) with anesthesia and the eye dryness score (EDS) measured on a 100-mm visual analog scale (0 = no discomfort, 100 = maximal discomfort). Least-squares mean treatment differences were derived from analysis of covariance (ANCOVA) models.
    Results: Overall, 449 female participants in the ONSET-1 and ONSET-2 trials randomized to the OC-01 (varenicline solution) nasal spray 0.03 mg or VC groups were included in this analysis. The treatment-menopausal status interaction terms in the STS and EDS ANCOVA and logistic regression models were not statistically significant (p > 0.05), indicating consistency of treatment effect between the PM- and PM+ groups. The treatment difference in STS was similar in the PM- and PM+ groups (6.7 and 5.5 mm, respectively). The treatment difference in EDS was similar in the PM- and PM+ groups (- 5.5 and - 4.1, respectively).
    Conclusions: OC-01 (varenicline solution) nasal spray demonstrated similar efficacy in promoting natural tear production and improving symptoms in both PM- and PM+ groups. As menopausal-related hormonal changes may be associated with more severe DED, these results may support OC-01 (varenicline solution) nasal spray as an effective treatment for DED in women regardless of presenting menopausal status.
    Trial registration: Post hoc subgroup analysis of data integrated from ONSET-1 (ClinicalTrials.gov identifier NCT03636061) and ONSET-2 (ClinicalTrials.gov identifier NCT04036292).
    Sprache Englisch
    Erscheinungsdatum 2022-11-18
    Erscheinungsland England
    Dokumenttyp Journal Article
    ISSN 2193-8245
    ISSN 2193-8245
    DOI 10.1007/s40123-022-00607-7
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel ; Online: Bilateral Effect of OC-01 (Varenicline Solution) Nasal Spray for Treatment of Signs and Symptoms in Individuals with Mild, Moderate, and Severe Dry Eye Disease.

    Katz, James / Periman, Laura M / Maiti, Sathi / Sarnicola, Enrica / Hemphill, Mandy / Kabat, Alan G / Hendrix, Laura H / Shah, Puja / Gibson, Andrea

    Clinical therapeutics

    2022  Band 44, Heft 11, Seite(n) 1463–1470

    Abstract: Purpose: This study compares outcomes of therapy with OC-01 (varenicline solution) for dry eye disease in study eyes and nonstudy fellow eyes of participants in 2 pivotal clinical trials.: Methods: All 891 patients randomized to receive OC-01 ( ... ...

    Abstract Purpose: This study compares outcomes of therapy with OC-01 (varenicline solution) for dry eye disease in study eyes and nonstudy fellow eyes of participants in 2 pivotal clinical trials.
    Methods: All 891 patients randomized to receive OC-01 (varenicline solution) 0.03 mg, OC-01 (varenicline solution) 0.06 mg, or vehicle control (VC) in each nostril twice daily for 28 days in the Phase IIb ONSET-1 (Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease) and Phase III ONSET-2 trials were included in this post hoc analysis. One eye was designated as the study eye. The mean change from baseline in anesthetized Schirmer test score (STS) and the percentage of eyes achieving a ≥10-mm STS improvement were compared between treatments in study and fellow eyes overall and by baseline Eye Dryness Score.
    Findings: In the study eyes, the mean STS improvement from baseline to day 28 was 10.4 mm, 10.5 mm, and 4.9 mm in the 0.03 mg, 0.06 mg, and VC groups, respectively; comparable values in nonstudy fellow eyes were 8.7 mm, 8.8 mm, and 2.7 mm, respectively. The percentages of study eyes achieving a ≥10-mm STS improvement were 48.1%, 48.4%, and 25.9%, respectively, whereas the comparable values in nonstudy eyes were 42.9%, 43.9%, and 19.7%, respectively. No significant treatment-subgroup interactions were observed in study or fellow eye STS outcomes by baseline Eye Dryness Scores <40 and ≥40 (p > 0.05 for all).
    Implications: OC-01 (varenicline solution) nasal spray had significant tear film production improvements compared with VC in both study and fellow eyes. These findings suggest efficacy across a broad spectrum of presenting disease severity.
    Mesh-Begriff(e) Humans ; Nasal Sprays ; Varenicline ; Dry Eye Syndromes/drug therapy
    Chemische Substanzen Nasal Sprays ; Varenicline (W6HS99O8ZO)
    Sprache Englisch
    Erscheinungsdatum 2022-10-28
    Erscheinungsland United States
    Dokumenttyp Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 603113-4
    ISSN 1879-114X ; 0149-2918
    ISSN (online) 1879-114X
    ISSN 0149-2918
    DOI 10.1016/j.clinthera.2022.09.013
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: Does Dry Eye Disease Severity Impact Efficacy of Varenicline Solution Nasal Spray on Sign and Symptom Treatment Outcomes?

    Sheppard, John D / O'Dell, Leslie E / Karpecki, Paul M / Raizman, Michael B / Whitley, Walter O / Blemker, Gretchen / Hemphill, Mandy / Hendrix, Laura H / Gibson, Andrea / Macsai, Marian

    Optometry and vision science : official publication of the American Academy of Optometry

    2022  Band 100, Heft 2, Seite(n) 164–169

    Abstract: Significance: There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface-sparing nasal spray ... ...

    Abstract Significance: There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface-sparing nasal spray therapy, demonstrated significant improvement in both signs and symptoms of dry eye disease in subjects with mild, moderate, and severe symptoms as the clinical studies enrolled a more real-world patient population.
    Purpose: This study evaluated efficacy outcomes for VNS in patients with mild-moderate and severe dry eye disease.
    Methods: An analysis of integrated data from two randomized clinical trials, ONSET-1 (NCT03636061) and ONSET-2 (NCT04036292) (vehicle control [VC], n = 294; VNS 0.03 mg, n = 308), was performed. Adults 22 years or older with dry eye disease, Ocular Surface Disease Index score of ≥23, corneal fluorescein staining score of ≥2 in ≥1 regions/≥4 all regions, and Schirmer Test Score (STS) of ≤10 mm (no restrictions on Eye Dryness Score [EDS]) were included in this study. Efficacy was evaluated using analysis of covariance among pre-specified subgroups of mild-moderate and severe baseline disease severity defined by STS (≤5 vs. >5) and EDS (<60 vs. ≥60). Consistency of effect was evaluated by interaction tests.
    Results: No treatment-subgroup interactions were observed for all end points ( P > .05). The odds of achieving a ≥10-mm improvement in STS for VNS versus VC for patients with baseline STS ≤5 and >5 were 3.4(95% confidence interval, 2.0 to 5.6) and 2.3(1.3 to 4.0) and for EDS of <60 and ≥60 were 3.4(1.9 to 6.1) and 2.5(1.5 to 4.0). Least-squares mean treatment/VC differences in change from baseline in EDS for patients with baseline STS ≤5 or >5 were -7.4(95% confidence interval, -12.5 to -2.4) and -2.8(-8.7 to 3.1); EDS of <60 and ≥60 were -2.9(-8.3 to 2.5) and -8.1(-13.6 to -2.6).
    Conclusions: Compared with VC, VNS improved tear production and patient-reported symptoms in patients with dry eye disease, demonstrating consistency of effect regardless of initial presenting severity.
    Mesh-Begriff(e) Adult ; Humans ; Dry Eye Syndromes/drug therapy ; Nasal Sprays ; Ophthalmic Solutions ; Patient Acuity ; Tears ; Treatment Outcome ; Varenicline/therapeutic use
    Chemische Substanzen Nasal Sprays ; Ophthalmic Solutions ; Varenicline (W6HS99O8ZO)
    Sprache Englisch
    Erscheinungsdatum 2022-12-31
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Randomized Controlled Trial
    ZDB-ID 1001706-9
    ISSN 1538-9235 ; 1040-5488
    ISSN (online) 1538-9235
    ISSN 1040-5488
    DOI 10.1097/OPX.0000000000001986
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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