Reversibility of Dry Eye Deceleration After Topical Cyclosporine 0.05% Withdrawal
To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis(®); Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh...
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| description | To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis(®); Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh Endura(®); Allergan, Inc., Irvine, CA) or cyclosporine 0.05%.
This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs-Cs; n=20) or artificial tears (Cs-At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At-Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12.
At baseline, most patients with Cs-Cs and Cs-At (>90%) had level 2 disease severity, whereas almost half of the patients with At-Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity (P |
| doi_str_mv | 10.1089/jop.2011.0073 |
| format | Article |
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This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs-Cs; n=20) or artificial tears (Cs-At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At-Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12.
At baseline, most patients with Cs-Cs and Cs-At (>90%) had level 2 disease severity, whereas almost half of the patients with At-Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity (P<0.001); whereas half of patients with Cs-At, compared with patients with no Cs-Cs and At-Cs, had disease progression at month 12. Throughout the study, dry eye signs and symptoms continuously improved in patients with Cs-Cs and At-Cs, whereas they constantly worsened in patients with Cs-At. At month 12, patients with Cs-Cs and At-Cs had significantly greater mean percentage improvement from baseline than did patients with Cs-At in Schirmer test scores, tear breakup time, Oxford staining scores, Ocular Surface Disease Index scores, and conjunctival goblet cell density (P<0.001). Overall, sign and symptom scores of patients with At-Cs did not improve as much as they did for patients with Cs-Cs.
Cyclosporine 0.05% withdrawal led to disease progression, thus indicating the necessity for maintenance therapy. Earlier treatment with cyclosporine 0.05% may result in improved outcomes.</description><identifier>ISSN: 1080-7683</identifier><identifier>EISSN: 1557-7732</identifier><identifier>DOI: 10.1089/jop.2011.0073</identifier><identifier>PMID: 21999340</identifier><language>eng</language><publisher>Larchmont, NY: Liebert</publisher><subject>Biological and medical sciences ; Cell Count ; Cyclosporine - administration & dosage ; Cyclosporine - adverse effects ; Cyclosporine - therapeutic use ; Disease Progression ; Drug Administration Schedule ; Dry Eye Syndromes - drug therapy ; Dry Eye Syndromes - pathology ; Female ; Goblet Cells - pathology ; Humans ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - adverse effects ; Immunosuppressive Agents - therapeutic use ; Longitudinal Studies ; Male ; Medical sciences ; Middle Aged ; Ophthalmic Solutions - administration & dosage ; Ophthalmic Solutions - adverse effects ; Ophthalmic Solutions - therapeutic use ; Pharmacology. Drug treatments ; Prospective Studies ; Severity of Illness Index ; Single-Blind Method ; Substance Withdrawal Syndrome</subject><ispartof>Journal of ocular pharmacology and therapeutics, 2011-12, Vol.27 (6), p.603-609</ispartof><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c322t-ae3128b75c5ba48fa48e490f9a100751841dd496d168e2b5fd633f85d2241e1a3</citedby><cites>FETCH-LOGICAL-c322t-ae3128b75c5ba48fa48e490f9a100751841dd496d168e2b5fd633f85d2241e1a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25363172$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21999340$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>RAO, Sanjay N</creatorcontrib><title>Reversibility of Dry Eye Deceleration After Topical Cyclosporine 0.05% Withdrawal</title><title>Journal of ocular pharmacology and therapeutics</title><addtitle>J Ocul Pharmacol Ther</addtitle><description>To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis(®); Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh Endura(®); Allergan, Inc., Irvine, CA) or cyclosporine 0.05%.
This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs-Cs; n=20) or artificial tears (Cs-At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At-Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12.
At baseline, most patients with Cs-Cs and Cs-At (>90%) had level 2 disease severity, whereas almost half of the patients with At-Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity (P<0.001); whereas half of patients with Cs-At, compared with patients with no Cs-Cs and At-Cs, had disease progression at month 12. Throughout the study, dry eye signs and symptoms continuously improved in patients with Cs-Cs and At-Cs, whereas they constantly worsened in patients with Cs-At. At month 12, patients with Cs-Cs and At-Cs had significantly greater mean percentage improvement from baseline than did patients with Cs-At in Schirmer test scores, tear breakup time, Oxford staining scores, Ocular Surface Disease Index scores, and conjunctival goblet cell density (P<0.001). Overall, sign and symptom scores of patients with At-Cs did not improve as much as they did for patients with Cs-Cs.
Cyclosporine 0.05% withdrawal led to disease progression, thus indicating the necessity for maintenance therapy. Earlier treatment with cyclosporine 0.05% may result in improved outcomes.</description><subject>Biological and medical sciences</subject><subject>Cell Count</subject><subject>Cyclosporine - administration & dosage</subject><subject>Cyclosporine - adverse effects</subject><subject>Cyclosporine - therapeutic use</subject><subject>Disease Progression</subject><subject>Drug Administration Schedule</subject><subject>Dry Eye Syndromes - drug therapy</subject><subject>Dry Eye Syndromes - pathology</subject><subject>Female</subject><subject>Goblet Cells - pathology</subject><subject>Humans</subject><subject>Immunosuppressive Agents - administration & dosage</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Longitudinal Studies</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Ophthalmic Solutions - administration & dosage</subject><subject>Ophthalmic Solutions - adverse effects</subject><subject>Ophthalmic Solutions - therapeutic use</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Severity of Illness Index</subject><subject>Single-Blind Method</subject><subject>Substance Withdrawal Syndrome</subject><issn>1080-7683</issn><issn>1557-7732</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkM9LwzAUx4MoOqdHr5LL8NSZlzRtcxxz_gBBFMVjSdsXzOiWmnRK_3szNvXw-L7Dhy_vfQi5ADYFVqjrpeumnAFMGcvFARmBlHmS54Ifxp0VLMmzQpyQ0xCWjIFgGRyTEw5KKZGyEXl-wS_0wVa2tf1AnaE3fqCLAekN1tii1711azozPXr66jpb65bOh7p1oXPerpGyKZMT-m77j8brb92ekSOj24Dn-xyTt9vF6_w-eXy6e5jPHpNacN4nGgXwosplLSudFiYOpooZpSF-IqFIoWlSlTWQFcgraZpMCFPIhvMUELQYk6tdb-fd5wZDX65siCe3eo1uE0oFoFKZChbJZEfW3oXg0ZSdtyvthxJYuZVYRonlVmK5lRj5y33zplph80f_WovAZA_oEH0Yr9e1Df-cFJmAnIsfr4x4ng</recordid><startdate>20111201</startdate><enddate>20111201</enddate><creator>RAO, Sanjay N</creator><general>Liebert</general><scope>IQODW</scope><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></search><sort><creationdate>20111201</creationdate><title>Reversibility of Dry Eye Deceleration After Topical Cyclosporine 0.05% Withdrawal</title><author>RAO, Sanjay N</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c322t-ae3128b75c5ba48fa48e490f9a100751841dd496d168e2b5fd633f85d2241e1a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Biological and medical sciences</topic><topic>Cell Count</topic><topic>Cyclosporine - administration & dosage</topic><topic>Cyclosporine - adverse effects</topic><topic>Cyclosporine - therapeutic use</topic><topic>Disease Progression</topic><topic>Drug Administration Schedule</topic><topic>Dry Eye Syndromes - drug therapy</topic><topic>Dry Eye Syndromes - pathology</topic><topic>Female</topic><topic>Goblet Cells - pathology</topic><topic>Humans</topic><topic>Immunosuppressive Agents - administration & dosage</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Longitudinal Studies</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Ophthalmic Solutions - administration & dosage</topic><topic>Ophthalmic Solutions - adverse effects</topic><topic>Ophthalmic Solutions - therapeutic use</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Severity of Illness Index</topic><topic>Single-Blind Method</topic><topic>Substance Withdrawal Syndrome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>RAO, Sanjay N</creatorcontrib><collection>Pascal-Francis</collection><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>Journal of ocular pharmacology and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>RAO, Sanjay N</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reversibility of Dry Eye Deceleration After Topical Cyclosporine 0.05% Withdrawal</atitle><jtitle>Journal of ocular pharmacology and therapeutics</jtitle><addtitle>J Ocul Pharmacol Ther</addtitle><date>2011-12-01</date><risdate>2011</risdate><volume>27</volume><issue>6</issue><spage>603</spage><epage>609</epage><pages>603-609</pages><issn>1080-7683</issn><eissn>1557-7732</eissn><abstract>To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis(®); Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh Endura(®); Allergan, Inc., Irvine, CA) or cyclosporine 0.05%.
This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs-Cs; n=20) or artificial tears (Cs-At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At-Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12.
At baseline, most patients with Cs-Cs and Cs-At (>90%) had level 2 disease severity, whereas almost half of the patients with At-Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity (P<0.001); whereas half of patients with Cs-At, compared with patients with no Cs-Cs and At-Cs, had disease progression at month 12. Throughout the study, dry eye signs and symptoms continuously improved in patients with Cs-Cs and At-Cs, whereas they constantly worsened in patients with Cs-At. At month 12, patients with Cs-Cs and At-Cs had significantly greater mean percentage improvement from baseline than did patients with Cs-At in Schirmer test scores, tear breakup time, Oxford staining scores, Ocular Surface Disease Index scores, and conjunctival goblet cell density (P<0.001). Overall, sign and symptom scores of patients with At-Cs did not improve as much as they did for patients with Cs-Cs.
Cyclosporine 0.05% withdrawal led to disease progression, thus indicating the necessity for maintenance therapy. Earlier treatment with cyclosporine 0.05% may result in improved outcomes.</abstract><cop>Larchmont, NY</cop><pub>Liebert</pub><pmid>21999340</pmid><doi>10.1089/jop.2011.0073</doi><tpages>7</tpages></addata></record> |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Biological and medical sciences Cell Count Cyclosporine - administration & dosage Cyclosporine - adverse effects Cyclosporine - therapeutic use Disease Progression Drug Administration Schedule Dry Eye Syndromes - drug therapy Dry Eye Syndromes - pathology Female Goblet Cells - pathology Humans Immunosuppressive Agents - administration & dosage Immunosuppressive Agents - adverse effects Immunosuppressive Agents - therapeutic use Longitudinal Studies Male Medical sciences Middle Aged Ophthalmic Solutions - administration & dosage Ophthalmic Solutions - adverse effects Ophthalmic Solutions - therapeutic use Pharmacology. Drug treatments Prospective Studies Severity of Illness Index Single-Blind Method Substance Withdrawal Syndrome |
| title | Reversibility of Dry Eye Deceleration After Topical Cyclosporine 0.05% Withdrawal |
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