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Subconjunctival liposomal sirolimus vs. cyclosporine or tacrolimus as treatment of keratoconjunctivitis sicca in dogs: A double‐blind, randomized study

Purpose To compare the safety and efficacy of a 100 microgram subconjunctival injection of liposome‐encapsulated sirolimus (SCJS) to cyclosporine (CsA) or tacrolimus (CsA/T) for the treatment of keratoconjunctivitis sicca (KCS) in dogs. Methods Dogs with signs and symptoms of KCS were block‐randomiz...

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Published in:Veterinary ophthalmology 2024-09, Vol.27 (5), p.461-468
Main Authors: García‐Santisteban, Rodrigo, Linares‐Alba, Mónica Anayatzin, Botello‐Bárcenas, Andrés, Margay, Paola, Soto, Carlos, Fonzar‐Furtado, Joice, Brooks, Dennis, García, Diego, Sánchez, Gustavo Adolfo García
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container_end_page 468
container_issue 5
container_start_page 461
container_title Veterinary ophthalmology
container_volume 27
creator García‐Santisteban, Rodrigo
Linares‐Alba, Mónica Anayatzin
Botello‐Bárcenas, Andrés
Margay, Paola
Soto, Carlos
Fonzar‐Furtado, Joice
Brooks, Dennis
García, Diego
Sánchez, Gustavo Adolfo García
description Purpose To compare the safety and efficacy of a 100 microgram subconjunctival injection of liposome‐encapsulated sirolimus (SCJS) to cyclosporine (CsA) or tacrolimus (CsA/T) for the treatment of keratoconjunctivitis sicca (KCS) in dogs. Methods Dogs with signs and symptoms of KCS were block‐randomized to one of two treatment groups: Biweekly SCJS or conventional treatment (CsA/T). Schirmer tear test 1 (STT‐1) scores, conjunctival hyperemia (CH) scores, corneal opacity (CO) scores, and clinical evaluation of potential side effects were recorded every 2 weeks for 14 weeks for both groups. Differences between groups were analyzed using the mixed results ANOVA and U‐Mann Whitney tests (p 
doi_str_mv 10.1111/vop.13190
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Methods Dogs with signs and symptoms of KCS were block‐randomized to one of two treatment groups: Biweekly SCJS or conventional treatment (CsA/T). Schirmer tear test 1 (STT‐1) scores, conjunctival hyperemia (CH) scores, corneal opacity (CO) scores, and clinical evaluation of potential side effects were recorded every 2 weeks for 14 weeks for both groups. Differences between groups were analyzed using the mixed results ANOVA and U‐Mann Whitney tests (p &lt; .05 was considered significant). Results A total of 30 eyes were included in the study, of which 20 eyes completed follow‐up. There was no statistically significant interaction between the treatment group and time on STT‐1 score (p = .165), and median CH and CO scores showed no statistically significant differences between groups (p = .353 and p = .393, respectively). There were no clinically significant side effects present in any subject at any time. Conclusion In this trial, a 1 mg/mL (100 micrograms) SCJS every 2 weeks showed similar safety and efficacy profiles as daily CsA/T in dogs with KS after 14 weeks of treatment. Larger studies should be performed to further assess SCJS as an alternative treatment for KCS.</description><identifier>ISSN: 1463-5216</identifier><identifier>ISSN: 1463-5224</identifier><identifier>EISSN: 1463-5224</identifier><identifier>DOI: 10.1111/vop.13190</identifier><identifier>PMID: 38329299</identifier><language>eng</language><publisher>England</publisher><subject>Animals ; Cyclosporine - administration &amp; dosage ; Cyclosporine - therapeutic use ; Dog Diseases - drug therapy ; Dogs ; Double-Blind Method ; dry eye ; Female ; Immunosuppressive Agents - administration &amp; dosage ; Immunosuppressive Agents - therapeutic use ; Keratoconjunctivitis Sicca - drug therapy ; Keratoconjunctivitis Sicca - veterinary ; Liposomes ; Male ; nanotechnology ; Sirolimus ; Sirolimus - administration &amp; dosage ; Sirolimus - therapeutic use ; Tacrolimus - administration &amp; dosage ; Tacrolimus - therapeutic use ; Treatment Outcome</subject><ispartof>Veterinary ophthalmology, 2024-09, Vol.27 (5), p.461-468</ispartof><rights>2024 American College of Veterinary Ophthalmologists.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c2850-5e38ed9bcd0238a870019090e09833607f43b75c7594db84a96b7c27e4d5b4e03</cites><orcidid>0000-0002-7939-5222</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38329299$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>García‐Santisteban, Rodrigo</creatorcontrib><creatorcontrib>Linares‐Alba, Mónica Anayatzin</creatorcontrib><creatorcontrib>Botello‐Bárcenas, Andrés</creatorcontrib><creatorcontrib>Margay, Paola</creatorcontrib><creatorcontrib>Soto, Carlos</creatorcontrib><creatorcontrib>Fonzar‐Furtado, Joice</creatorcontrib><creatorcontrib>Brooks, Dennis</creatorcontrib><creatorcontrib>García, Diego</creatorcontrib><creatorcontrib>Sánchez, Gustavo Adolfo García</creatorcontrib><title>Subconjunctival liposomal sirolimus vs. cyclosporine or tacrolimus as treatment of keratoconjunctivitis sicca in dogs: A double‐blind, randomized study</title><title>Veterinary ophthalmology</title><addtitle>Vet Ophthalmol</addtitle><description>Purpose To compare the safety and efficacy of a 100 microgram subconjunctival injection of liposome‐encapsulated sirolimus (SCJS) to cyclosporine (CsA) or tacrolimus (CsA/T) for the treatment of keratoconjunctivitis sicca (KCS) in dogs. Methods Dogs with signs and symptoms of KCS were block‐randomized to one of two treatment groups: Biweekly SCJS or conventional treatment (CsA/T). Schirmer tear test 1 (STT‐1) scores, conjunctival hyperemia (CH) scores, corneal opacity (CO) scores, and clinical evaluation of potential side effects were recorded every 2 weeks for 14 weeks for both groups. Differences between groups were analyzed using the mixed results ANOVA and U‐Mann Whitney tests (p &lt; .05 was considered significant). Results A total of 30 eyes were included in the study, of which 20 eyes completed follow‐up. There was no statistically significant interaction between the treatment group and time on STT‐1 score (p = .165), and median CH and CO scores showed no statistically significant differences between groups (p = .353 and p = .393, respectively). There were no clinically significant side effects present in any subject at any time. Conclusion In this trial, a 1 mg/mL (100 micrograms) SCJS every 2 weeks showed similar safety and efficacy profiles as daily CsA/T in dogs with KS after 14 weeks of treatment. Larger studies should be performed to further assess SCJS as an alternative treatment for KCS.</description><subject>Animals</subject><subject>Cyclosporine - administration &amp; dosage</subject><subject>Cyclosporine - therapeutic use</subject><subject>Dog Diseases - drug therapy</subject><subject>Dogs</subject><subject>Double-Blind Method</subject><subject>dry eye</subject><subject>Female</subject><subject>Immunosuppressive Agents - administration &amp; dosage</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Keratoconjunctivitis Sicca - drug therapy</subject><subject>Keratoconjunctivitis Sicca - veterinary</subject><subject>Liposomes</subject><subject>Male</subject><subject>nanotechnology</subject><subject>Sirolimus</subject><subject>Sirolimus - administration &amp; dosage</subject><subject>Sirolimus - therapeutic use</subject><subject>Tacrolimus - administration &amp; dosage</subject><subject>Tacrolimus - therapeutic use</subject><subject>Treatment Outcome</subject><issn>1463-5216</issn><issn>1463-5224</issn><issn>1463-5224</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp1kclOHDEQhq0IFJbkkBdAPgaJGex2b84NobBISETKcm15qUEm7nbH5Z5oOPEIXHm9PEkMw3LClyqpPn2S_5-QT5zNeX6HyzDOueCSvSPbvKzFrCqKcuNl5_UW2UG8ZoyJijXvyZZoRSELKbfJ_fdJmzBcT4NJbqk89W4MGPq8oYvBu35CusQ5NSvjA44hugFoiDQp83xWSFMElXoYEg0L-huiSuHV6pLDbDNGUTdQG67wCz3Kc9Ie_t3eae8Ge0CjGmzo3Q1Yimmyqw9kc6E8wsenuUt-nnz9cXw2u7g8PT8-upiZoq3YrALRgpXaWFaIVrUNYzkIyYDJVoiaNYtS6KYyTSVLq9tSyVo3pmigtJUugYld8nntHWP4MwGmrndowHs1QJiwy0EJyXlRtxndX6P564gRFt0YXa_iquOse2iiy010j01kdu9JO-ke7Av5HH0GDtfAX-dh9bap-3X5ba38D7iKlzk</recordid><startdate>202409</startdate><enddate>202409</enddate><creator>García‐Santisteban, Rodrigo</creator><creator>Linares‐Alba, Mónica Anayatzin</creator><creator>Botello‐Bárcenas, Andrés</creator><creator>Margay, Paola</creator><creator>Soto, Carlos</creator><creator>Fonzar‐Furtado, Joice</creator><creator>Brooks, Dennis</creator><creator>García, Diego</creator><creator>Sánchez, Gustavo Adolfo García</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7939-5222</orcidid></search><sort><creationdate>202409</creationdate><title>Subconjunctival liposomal sirolimus vs. cyclosporine or tacrolimus as treatment of keratoconjunctivitis sicca in dogs: A double‐blind, randomized study</title><author>García‐Santisteban, Rodrigo ; Linares‐Alba, Mónica Anayatzin ; Botello‐Bárcenas, Andrés ; Margay, Paola ; Soto, Carlos ; Fonzar‐Furtado, Joice ; Brooks, Dennis ; García, Diego ; Sánchez, Gustavo Adolfo García</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2850-5e38ed9bcd0238a870019090e09833607f43b75c7594db84a96b7c27e4d5b4e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Animals</topic><topic>Cyclosporine - administration &amp; dosage</topic><topic>Cyclosporine - therapeutic use</topic><topic>Dog Diseases - drug therapy</topic><topic>Dogs</topic><topic>Double-Blind Method</topic><topic>dry eye</topic><topic>Female</topic><topic>Immunosuppressive Agents - administration &amp; dosage</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Keratoconjunctivitis Sicca - drug therapy</topic><topic>Keratoconjunctivitis Sicca - veterinary</topic><topic>Liposomes</topic><topic>Male</topic><topic>nanotechnology</topic><topic>Sirolimus</topic><topic>Sirolimus - administration &amp; dosage</topic><topic>Sirolimus - therapeutic use</topic><topic>Tacrolimus - administration &amp; dosage</topic><topic>Tacrolimus - therapeutic use</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>García‐Santisteban, Rodrigo</creatorcontrib><creatorcontrib>Linares‐Alba, Mónica Anayatzin</creatorcontrib><creatorcontrib>Botello‐Bárcenas, Andrés</creatorcontrib><creatorcontrib>Margay, Paola</creatorcontrib><creatorcontrib>Soto, Carlos</creatorcontrib><creatorcontrib>Fonzar‐Furtado, Joice</creatorcontrib><creatorcontrib>Brooks, Dennis</creatorcontrib><creatorcontrib>García, Diego</creatorcontrib><creatorcontrib>Sánchez, Gustavo Adolfo García</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Veterinary ophthalmology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>García‐Santisteban, Rodrigo</au><au>Linares‐Alba, Mónica Anayatzin</au><au>Botello‐Bárcenas, Andrés</au><au>Margay, Paola</au><au>Soto, Carlos</au><au>Fonzar‐Furtado, Joice</au><au>Brooks, Dennis</au><au>García, Diego</au><au>Sánchez, Gustavo Adolfo García</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Subconjunctival liposomal sirolimus vs. cyclosporine or tacrolimus as treatment of keratoconjunctivitis sicca in dogs: A double‐blind, randomized study</atitle><jtitle>Veterinary ophthalmology</jtitle><addtitle>Vet Ophthalmol</addtitle><date>2024-09</date><risdate>2024</risdate><volume>27</volume><issue>5</issue><spage>461</spage><epage>468</epage><pages>461-468</pages><issn>1463-5216</issn><issn>1463-5224</issn><eissn>1463-5224</eissn><abstract>Purpose To compare the safety and efficacy of a 100 microgram subconjunctival injection of liposome‐encapsulated sirolimus (SCJS) to cyclosporine (CsA) or tacrolimus (CsA/T) for the treatment of keratoconjunctivitis sicca (KCS) in dogs. Methods Dogs with signs and symptoms of KCS were block‐randomized to one of two treatment groups: Biweekly SCJS or conventional treatment (CsA/T). Schirmer tear test 1 (STT‐1) scores, conjunctival hyperemia (CH) scores, corneal opacity (CO) scores, and clinical evaluation of potential side effects were recorded every 2 weeks for 14 weeks for both groups. Differences between groups were analyzed using the mixed results ANOVA and U‐Mann Whitney tests (p &lt; .05 was considered significant). Results A total of 30 eyes were included in the study, of which 20 eyes completed follow‐up. There was no statistically significant interaction between the treatment group and time on STT‐1 score (p = .165), and median CH and CO scores showed no statistically significant differences between groups (p = .353 and p = .393, respectively). There were no clinically significant side effects present in any subject at any time. Conclusion In this trial, a 1 mg/mL (100 micrograms) SCJS every 2 weeks showed similar safety and efficacy profiles as daily CsA/T in dogs with KS after 14 weeks of treatment. Larger studies should be performed to further assess SCJS as an alternative treatment for KCS.</abstract><cop>England</cop><pmid>38329299</pmid><doi>10.1111/vop.13190</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-7939-5222</orcidid></addata></record>
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ispartof Veterinary ophthalmology, 2024-09, Vol.27 (5), p.461-468
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1463-5224
1463-5224
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recordid cdi_proquest_miscellaneous_2923911268
source Wiley
subjects Animals
Cyclosporine - administration & dosage
Cyclosporine - therapeutic use
Dog Diseases - drug therapy
Dogs
Double-Blind Method
dry eye
Female
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - therapeutic use
Keratoconjunctivitis Sicca - drug therapy
Keratoconjunctivitis Sicca - veterinary
Liposomes
Male
nanotechnology
Sirolimus
Sirolimus - administration & dosage
Sirolimus - therapeutic use
Tacrolimus - administration & dosage
Tacrolimus - therapeutic use
Treatment Outcome
title Subconjunctival liposomal sirolimus vs. cyclosporine or tacrolimus as treatment of keratoconjunctivitis sicca in dogs: A double‐blind, randomized study
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