The Experts below are selected from a list of 78 Experts worldwide ranked by ideXlab platform

David A Hollander - One of the best experts on this subject based on the ideXlab platform.

  • Alcaftadine 0 25 versus olopatadine 0 1 in preventing cedar pollen allergic conjunctivitis in japan a randomized study
    Ocular Immunology and Inflammation, 2019
    Co-Authors: Hiroshi Nakatani, Paul J Gomes, R Bradford, Eleonora Safyan, David A Hollander
    Abstract:

    ABSTRACTPurpose: To compare Alcaftadine and olopatadine ophthalmic solutions, and vehicle for preventing allergen-mediated conjunctivitis in Japanese subjects.Methods: Japanese cedar pollen-sensitive subjects were randomized to Alcaftadine 0.25%, olopatadine 0.1%, or vehicle. Ocular itching was assessed at 3, 5 (primary outcome), 7, and 15 min post-conjunctival allergen challenge (CAC) and conjunctival hyperemia assessed at 7, 15 (secondary outcome), and 20 min post-CAC. Adverse events were monitored.Results: Overall, 240 subjects were randomized. Alcaftadine 0.25% (challenged 8 h post-dose) was significantly more effective than vehicle for prevention of itching and conjunctival hyperemia (p < 0.001) and noninferior to olopatadine 0.1% (challenged 4 h post-dose). Significantly lower hyperemia scores were observed in Alcaftadine-treated than olopatadine-treated eyes at 7 and 15 min post-CAC (p ≤ 0.027). Alcaftadine and olopatadine were well tolerated; no serious adverse events were reported.Conclusion: Alc...

  • effect of Alcaftadine 0 25 on ocular itch associated with seasonal or perennial allergic conjunctivitis a pooled analysis of two multicenter randomized clinical trials
    Clinical Ophthalmology, 2015
    Co-Authors: Joseph B Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily Alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis. Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with Alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score 1) and zero itch (itch score =0), and safety were also assessed. Results: A total of 189 subjects enrolled in the two studies were treated with Alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens ( P0.0001 at all time points) and those challenged with perennial allergens (0.0001 at all time points). A higher percentage of subjects treated with Alcaftadine compared with placebo achieved minimal itch (P0.001 versus placebo at all time points) and zero itch (P0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported. Conclusion: Once-daily Alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis.

  • Ocular Itch Relief with Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis: Pooled Analysis of Two Multicenter Randomized Clinical Trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated. Methods Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive Alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score

  • ocular itch relief with Alcaftadine 0 25 versus olopatadine 0 2 in allergic conjunctivitis pooled analysis of two multicenter randomized clinical trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

  • a multicenter evaluation of the efficacy and duration of action of Alcaftadine 0 25 and olopatadine 0 2 in the conjunctival allergen challenge model
    Journal of Asthma and Allergy, 2013
    Co-Authors: Stacey L Ackerman, Joseph B Ciolino, Linda Villanueva, Francis Dambrosio, Jack V Greiner, David A Hollander
    Abstract:

    Background: The purpose of this study was to evaluate the efficacy and duration of action of once-daily dosing with Alcaftadine 0.25% ophthalmic solution and olopatadine 0.2% ophthalmic solution as compared with placebo in the prevention of ocular itching, and to directly compare the efficacy of Alcaftadine 0.25% with olopatadine 0.2% in the prevention of ocular itching associated with allergic conjunctivitis using the conjunctival allergen challenge model. Methods: Subjects with allergic conjunctivitis (n = 127) were enrolled in a multicenter, double-masked, randomized, active-controlled and placebo-controlled clinical trial. Using the conjunctival allergen challenge model, this study was conducted over the course of approximately 5 weeks. Subjects were randomized into one of three treatment arms: Alcaftadine 0.25% ophthalmic solution, olopatadine 0.2% ophthalmic solution, or placebo. Study medications were administered twice over the course of the trial. The primary efficacy measure for the study was ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge. Secondary endpoints, measured at 7, 15, and 20 minutes post challenge, included conjunctival, ciliary, and episcleral redness, lid swelling, chemosis, and tearing. Duration of action was measured at 16 and 24 hours post-instillation of the study medication at visits 3 and 4, respectively. Results: For the primary measure of ocular itching, both actives, Alcaftadine 0.25% and olopatadine 0.2%, were statistically superior to placebo at all three measured time points for both the 16-hour and 24-hour measures (P , 0.0001). Eyes treated with Alcaftadine 0.25% had numerically lower mean ocular itching scores than eyes treated with olopatadine 0.2% at every time point, and this difference was statistically significant at the 3-minute time point 16 hours post instillation (P = 0.026). Eyes treated with Alcaftadine 0.25% and with olopatadine 0.2% displayed significantly less lid swelling relative to placebo at every time point for the 16-hour and 24-hour post-instillation visits (P , 0.005). Alcaftadine 0.25% was the only active treatment that provided statistically significant relief of chemosis at every time point of the 24-hour post-instillation visit. Conclusion: Both the Alcaftadine 0.25% and olopatadine 0.2% ophthalmic solutions provided highly effective relief of ocular itching at both 16 and 24 hours post-instillation. Treatment differences between the actives were most pronounced at the earliest time point (3 minutes post-challenge) following conjunctival allergen challenge (16 hours), when Alcaftadine 0.25% ophthalmic solution was statistically superior to olopatadine 0.2% ophthalmic solution. Alcaftadine 0.25% was the only treatment to provide significant relief from chemosis at both 16 and 24 hours

Stacey L Ackerman - One of the best experts on this subject based on the ideXlab platform.

  • submit your manuscript | www.dovepress.com
    2016
    Co-Authors: Citation Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, Joseph B, Clinical Ophthalmology Dovepress
    Abstract:

    Effect of Alcaftadine 0.25 % on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials (Article begins on next page) The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters

  • effect of Alcaftadine 0 25 on ocular itch associated with seasonal or perennial allergic conjunctivitis a pooled analysis of two multicenter randomized clinical trials
    Clinical Ophthalmology, 2015
    Co-Authors: Joseph B Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily Alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis. Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with Alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score 1) and zero itch (itch score =0), and safety were also assessed. Results: A total of 189 subjects enrolled in the two studies were treated with Alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens ( P0.0001 at all time points) and those challenged with perennial allergens (0.0001 at all time points). A higher percentage of subjects treated with Alcaftadine compared with placebo achieved minimal itch (P0.001 versus placebo at all time points) and zero itch (P0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported. Conclusion: Once-daily Alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis.

  • Ocular Itch Relief with Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis: Pooled Analysis of Two Multicenter Randomized Clinical Trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated. Methods Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive Alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score

  • ocular itch relief with Alcaftadine 0 25 versus olopatadine 0 2 in allergic conjunctivitis pooled analysis of two multicenter randomized clinical trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

  • a multicenter evaluation of the efficacy and duration of action of Alcaftadine 0 25 and olopatadine 0 2 in the conjunctival allergen challenge model
    Journal of Asthma and Allergy, 2013
    Co-Authors: Stacey L Ackerman, Joseph B Ciolino, Linda Villanueva, Francis Dambrosio, Jack V Greiner, David A Hollander
    Abstract:

    Background: The purpose of this study was to evaluate the efficacy and duration of action of once-daily dosing with Alcaftadine 0.25% ophthalmic solution and olopatadine 0.2% ophthalmic solution as compared with placebo in the prevention of ocular itching, and to directly compare the efficacy of Alcaftadine 0.25% with olopatadine 0.2% in the prevention of ocular itching associated with allergic conjunctivitis using the conjunctival allergen challenge model. Methods: Subjects with allergic conjunctivitis (n = 127) were enrolled in a multicenter, double-masked, randomized, active-controlled and placebo-controlled clinical trial. Using the conjunctival allergen challenge model, this study was conducted over the course of approximately 5 weeks. Subjects were randomized into one of three treatment arms: Alcaftadine 0.25% ophthalmic solution, olopatadine 0.2% ophthalmic solution, or placebo. Study medications were administered twice over the course of the trial. The primary efficacy measure for the study was ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge. Secondary endpoints, measured at 7, 15, and 20 minutes post challenge, included conjunctival, ciliary, and episcleral redness, lid swelling, chemosis, and tearing. Duration of action was measured at 16 and 24 hours post-instillation of the study medication at visits 3 and 4, respectively. Results: For the primary measure of ocular itching, both actives, Alcaftadine 0.25% and olopatadine 0.2%, were statistically superior to placebo at all three measured time points for both the 16-hour and 24-hour measures (P , 0.0001). Eyes treated with Alcaftadine 0.25% had numerically lower mean ocular itching scores than eyes treated with olopatadine 0.2% at every time point, and this difference was statistically significant at the 3-minute time point 16 hours post instillation (P = 0.026). Eyes treated with Alcaftadine 0.25% and with olopatadine 0.2% displayed significantly less lid swelling relative to placebo at every time point for the 16-hour and 24-hour post-instillation visits (P , 0.005). Alcaftadine 0.25% was the only active treatment that provided statistically significant relief of chemosis at every time point of the 24-hour post-instillation visit. Conclusion: Both the Alcaftadine 0.25% and olopatadine 0.2% ophthalmic solutions provided highly effective relief of ocular itching at both 16 and 24 hours post-instillation. Treatment differences between the actives were most pronounced at the earliest time point (3 minutes post-challenge) following conjunctival allergen challenge (16 hours), when Alcaftadine 0.25% ophthalmic solution was statistically superior to olopatadine 0.2% ophthalmic solution. Alcaftadine 0.25% was the only treatment to provide significant relief from chemosis at both 16 and 24 hours

Linda Villanueva - One of the best experts on this subject based on the ideXlab platform.

  • submit your manuscript | www.dovepress.com
    2016
    Co-Authors: Citation Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, Joseph B, Clinical Ophthalmology Dovepress
    Abstract:

    Effect of Alcaftadine 0.25 % on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials (Article begins on next page) The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters

  • effect of Alcaftadine 0 25 on ocular itch associated with seasonal or perennial allergic conjunctivitis a pooled analysis of two multicenter randomized clinical trials
    Clinical Ophthalmology, 2015
    Co-Authors: Joseph B Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily Alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis. Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with Alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score 1) and zero itch (itch score =0), and safety were also assessed. Results: A total of 189 subjects enrolled in the two studies were treated with Alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens ( P0.0001 at all time points) and those challenged with perennial allergens (0.0001 at all time points). A higher percentage of subjects treated with Alcaftadine compared with placebo achieved minimal itch (P0.001 versus placebo at all time points) and zero itch (P0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported. Conclusion: Once-daily Alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis.

  • Ocular Itch Relief with Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis: Pooled Analysis of Two Multicenter Randomized Clinical Trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated. Methods Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive Alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score

  • ocular itch relief with Alcaftadine 0 25 versus olopatadine 0 2 in allergic conjunctivitis pooled analysis of two multicenter randomized clinical trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

  • a multicenter evaluation of the efficacy and duration of action of Alcaftadine 0 25 and olopatadine 0 2 in the conjunctival allergen challenge model
    Journal of Asthma and Allergy, 2013
    Co-Authors: Stacey L Ackerman, Joseph B Ciolino, Linda Villanueva, Francis Dambrosio, Jack V Greiner, David A Hollander
    Abstract:

    Background: The purpose of this study was to evaluate the efficacy and duration of action of once-daily dosing with Alcaftadine 0.25% ophthalmic solution and olopatadine 0.2% ophthalmic solution as compared with placebo in the prevention of ocular itching, and to directly compare the efficacy of Alcaftadine 0.25% with olopatadine 0.2% in the prevention of ocular itching associated with allergic conjunctivitis using the conjunctival allergen challenge model. Methods: Subjects with allergic conjunctivitis (n = 127) were enrolled in a multicenter, double-masked, randomized, active-controlled and placebo-controlled clinical trial. Using the conjunctival allergen challenge model, this study was conducted over the course of approximately 5 weeks. Subjects were randomized into one of three treatment arms: Alcaftadine 0.25% ophthalmic solution, olopatadine 0.2% ophthalmic solution, or placebo. Study medications were administered twice over the course of the trial. The primary efficacy measure for the study was ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge. Secondary endpoints, measured at 7, 15, and 20 minutes post challenge, included conjunctival, ciliary, and episcleral redness, lid swelling, chemosis, and tearing. Duration of action was measured at 16 and 24 hours post-instillation of the study medication at visits 3 and 4, respectively. Results: For the primary measure of ocular itching, both actives, Alcaftadine 0.25% and olopatadine 0.2%, were statistically superior to placebo at all three measured time points for both the 16-hour and 24-hour measures (P , 0.0001). Eyes treated with Alcaftadine 0.25% had numerically lower mean ocular itching scores than eyes treated with olopatadine 0.2% at every time point, and this difference was statistically significant at the 3-minute time point 16 hours post instillation (P = 0.026). Eyes treated with Alcaftadine 0.25% and with olopatadine 0.2% displayed significantly less lid swelling relative to placebo at every time point for the 16-hour and 24-hour post-instillation visits (P , 0.005). Alcaftadine 0.25% was the only active treatment that provided statistically significant relief of chemosis at every time point of the 24-hour post-instillation visit. Conclusion: Both the Alcaftadine 0.25% and olopatadine 0.2% ophthalmic solutions provided highly effective relief of ocular itching at both 16 and 24 hours post-instillation. Treatment differences between the actives were most pronounced at the earliest time point (3 minutes post-challenge) following conjunctival allergen challenge (16 hours), when Alcaftadine 0.25% ophthalmic solution was statistically superior to olopatadine 0.2% ophthalmic solution. Alcaftadine 0.25% was the only treatment to provide significant relief from chemosis at both 16 and 24 hours

Eugene B Mclaurin - One of the best experts on this subject based on the ideXlab platform.

  • submit your manuscript | www.dovepress.com
    2016
    Co-Authors: Citation Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, Joseph B, Clinical Ophthalmology Dovepress
    Abstract:

    Effect of Alcaftadine 0.25 % on ocular itch associated with seasonal or perennial allergic conjunctivitis: a pooled analysis of two multicenter randomized clinical trials (Article begins on next page) The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters

  • effect of Alcaftadine 0 25 on ocular itch associated with seasonal or perennial allergic conjunctivitis a pooled analysis of two multicenter randomized clinical trials
    Clinical Ophthalmology, 2015
    Co-Authors: Joseph B Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily Alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis. Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with Alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score 1) and zero itch (itch score =0), and safety were also assessed. Results: A total of 189 subjects enrolled in the two studies were treated with Alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens ( P0.0001 at all time points) and those challenged with perennial allergens (0.0001 at all time points). A higher percentage of subjects treated with Alcaftadine compared with placebo achieved minimal itch (P0.001 versus placebo at all time points) and zero itch (P0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported. Conclusion: Once-daily Alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis.

  • Ocular Itch Relief with Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis: Pooled Analysis of Two Multicenter Randomized Clinical Trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated. Methods Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive Alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score

  • ocular itch relief with Alcaftadine 0 25 versus olopatadine 0 2 in allergic conjunctivitis pooled analysis of two multicenter randomized clinical trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

Joseph B Ciolino - One of the best experts on this subject based on the ideXlab platform.

  • effect of Alcaftadine 0 25 on ocular itch associated with seasonal or perennial allergic conjunctivitis a pooled analysis of two multicenter randomized clinical trials
    Clinical Ophthalmology, 2015
    Co-Authors: Joseph B Ciolino, Eugene B Mclaurin, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Purpose: Seasonal and perennial allergic conjunctivitis represent the majority of cases of ocular allergy. This analysis was designed to evaluate the efficacy and safety of once-daily Alcaftadine 0.25% in preventing ocular itching associated with seasonal or perennial allergic conjunctivitis. Subjects and methods: Pooled data from two double-masked, multicenter, placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis were analyzed. Subjects randomized to receive treatment with Alcaftadine 0.25% or placebo were challenged with seasonal (grass, ragweed, trees) or perennial (cat dander, cat hair, dog dander, dust mites, cockroach) allergens, 16 hours after treatment instillation. The primary efficacy measure was subject-evaluated mean ocular itching at 3 minutes post-CAC. Secondary measures included ocular itching at 5 and 7 minutes post-CAC. The proportion of subjects with minimal itch (itch score 1) and zero itch (itch score =0), and safety were also assessed. Results: A total of 189 subjects enrolled in the two studies were treated with Alcaftadine or placebo. Overall, 129 subjects were challenged with seasonal allergens and 60 subjects were challenged with perennial allergens. Alcaftadine 0.25% achieved a statistically significant reduction in mean itch score at 3, 5, and 7 minutes post-CAC compared with placebo in subjects challenged with seasonal allergens ( P0.0001 at all time points) and those challenged with perennial allergens (0.0001 at all time points). A higher percentage of subjects treated with Alcaftadine compared with placebo achieved minimal itch (P0.001 versus placebo at all time points) and zero itch (P0.05 at all time points except 7 minutes for perennial) when challenged with either seasonal or perennial allergens. No treatment-related or serious adverse events were reported. Conclusion: Once-daily Alcaftadine 0.25% ophthalmic solution was well tolerated and demonstrated effective relief of ocular itching in subjects challenged with allergens classic for triggering either seasonal or perennial allergic conjunctivitis.

  • Ocular Itch Relief with Alcaftadine 0.25% Versus Olopatadine 0.2% in Allergic Conjunctivitis: Pooled Analysis of Two Multicenter Randomized Clinical Trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated. Methods Pooled analysis was conducted of two double-masked, multicenter, active- and placebo-controlled studies using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis. Subjects were randomized 1:1:1 to receive Alcaftadine 0.25%, olopatadine 0.2%, or placebo. The primary efficacy measure was subject-evaluated mean ocular itching at 3 min post-CAC and 16 h after treatment instillation. Secondary measures included ocular itching at 5 and 7 min post-CAC. Ocular itch was determined over all time points measured (3, 5, and 7 min) post-CAC and the proportion of subjects with minimal itch (itch score

  • ocular itch relief with Alcaftadine 0 25 versus olopatadine 0 2 in allergic conjunctivitis pooled analysis of two multicenter randomized clinical trials
    Advances in Therapy, 2014
    Co-Authors: Eugene B Mclaurin, Joseph B Ciolino, Nicholas P Marsico, Stacey L Ackerman, Julia M Williams, Linda Villanueva, David A Hollander
    Abstract:

    Introduction The efficacy and safety of the once-daily topical ophthalmic solutions, Alcaftadine 0.25% and olopatadine 0.2%, in preventing ocular itching associated with allergic conjunctivitis were evaluated.

  • a multicenter evaluation of the efficacy and duration of action of Alcaftadine 0 25 and olopatadine 0 2 in the conjunctival allergen challenge model
    Journal of Asthma and Allergy, 2013
    Co-Authors: Stacey L Ackerman, Joseph B Ciolino, Linda Villanueva, Francis Dambrosio, Jack V Greiner, David A Hollander
    Abstract:

    Background: The purpose of this study was to evaluate the efficacy and duration of action of once-daily dosing with Alcaftadine 0.25% ophthalmic solution and olopatadine 0.2% ophthalmic solution as compared with placebo in the prevention of ocular itching, and to directly compare the efficacy of Alcaftadine 0.25% with olopatadine 0.2% in the prevention of ocular itching associated with allergic conjunctivitis using the conjunctival allergen challenge model. Methods: Subjects with allergic conjunctivitis (n = 127) were enrolled in a multicenter, double-masked, randomized, active-controlled and placebo-controlled clinical trial. Using the conjunctival allergen challenge model, this study was conducted over the course of approximately 5 weeks. Subjects were randomized into one of three treatment arms: Alcaftadine 0.25% ophthalmic solution, olopatadine 0.2% ophthalmic solution, or placebo. Study medications were administered twice over the course of the trial. The primary efficacy measure for the study was ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge. Secondary endpoints, measured at 7, 15, and 20 minutes post challenge, included conjunctival, ciliary, and episcleral redness, lid swelling, chemosis, and tearing. Duration of action was measured at 16 and 24 hours post-instillation of the study medication at visits 3 and 4, respectively. Results: For the primary measure of ocular itching, both actives, Alcaftadine 0.25% and olopatadine 0.2%, were statistically superior to placebo at all three measured time points for both the 16-hour and 24-hour measures (P , 0.0001). Eyes treated with Alcaftadine 0.25% had numerically lower mean ocular itching scores than eyes treated with olopatadine 0.2% at every time point, and this difference was statistically significant at the 3-minute time point 16 hours post instillation (P = 0.026). Eyes treated with Alcaftadine 0.25% and with olopatadine 0.2% displayed significantly less lid swelling relative to placebo at every time point for the 16-hour and 24-hour post-instillation visits (P , 0.005). Alcaftadine 0.25% was the only active treatment that provided statistically significant relief of chemosis at every time point of the 24-hour post-instillation visit. Conclusion: Both the Alcaftadine 0.25% and olopatadine 0.2% ophthalmic solutions provided highly effective relief of ocular itching at both 16 and 24 hours post-instillation. Treatment differences between the actives were most pronounced at the earliest time point (3 minutes post-challenge) following conjunctival allergen challenge (16 hours), when Alcaftadine 0.25% ophthalmic solution was statistically superior to olopatadine 0.2% ophthalmic solution. Alcaftadine 0.25% was the only treatment to provide significant relief from chemosis at both 16 and 24 hours