A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis
Introduction The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis. Methods A prospective, open-label, single-armed, phase II clinical trial in...
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Veröffentlicht in: | Advances in therapy 2009-08, Vol.26 (8), p.776-783 |
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description | Introduction
The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis.
Methods
A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector™ were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA.
Results
A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to follow-up.
Conclusions
An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted. |
doi_str_mv | 10.1007/s12325-009-0062-1 |
format | Article |
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The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis.
Methods
A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector™ were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA.
Results
A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to follow-up.
Conclusions
An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted.</description><identifier>ISSN: 0741-238X</identifier><identifier>EISSN: 1865-8652</identifier><identifier>DOI: 10.1007/s12325-009-0062-1</identifier><identifier>PMID: 19756415</identifier><language>eng</language><publisher>Heidelberg: Springer Healthcare Communications</publisher><subject>Acute Disease ; Adenovirus Infections, Human - diagnosis ; Adenovirus Infections, Human - drug therapy ; Adenovirus Infections, Human - virology ; Anti-Infective Agents, Local - therapeutic use ; Anti-Inflammatory Agents - therapeutic use ; Cardiology ; Conjunctivitis, Viral - diagnosis ; Conjunctivitis, Viral - drug therapy ; Conjunctivitis, Viral - virology ; Dexamethasone - therapeutic use ; Drug Administration Schedule ; Drug Combinations ; Endocrinology ; Fluorescent Antibody Technique ; Health technology assessment ; Humans ; Internal Medicine ; Medicine ; Medicine & Public Health ; Oncology ; Ophthalmic Solutions ; Original Research ; Pharmacology/Toxicology ; Pilot Projects ; Polymerase Chain Reaction ; Povidone-Iodine - therapeutic use ; Prospective Studies ; Rheumatology ; Treatment Outcome</subject><ispartof>Advances in therapy, 2009-08, Vol.26 (8), p.776-783</ispartof><rights>Springer Healthcare Communications 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-c0eaa5b8815be329f972c3b535ba36db00eb0513e2e70f37fdd8f88ec570a3a93</citedby><cites>FETCH-LOGICAL-c409t-c0eaa5b8815be329f972c3b535ba36db00eb0513e2e70f37fdd8f88ec570a3a93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12325-009-0062-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12325-009-0062-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19756415$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pelletier, J. S.</creatorcontrib><creatorcontrib>Stewart, K.</creatorcontrib><creatorcontrib>Trattler, W.</creatorcontrib><creatorcontrib>Ritterband, D. C.</creatorcontrib><creatorcontrib>Braverman, S.</creatorcontrib><creatorcontrib>Samson, C. M.</creatorcontrib><creatorcontrib>Liang, B.</creatorcontrib><creatorcontrib>Capriotti, J. A.</creatorcontrib><title>A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis</title><title>Advances in therapy</title><addtitle>Adv Therapy</addtitle><addtitle>Adv Ther</addtitle><description>Introduction
The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis.
Methods
A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector™ were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA.
Results
A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to follow-up.
Conclusions
An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted.</description><subject>Acute Disease</subject><subject>Adenovirus Infections, Human - diagnosis</subject><subject>Adenovirus Infections, Human - drug therapy</subject><subject>Adenovirus Infections, Human - virology</subject><subject>Anti-Infective Agents, Local - therapeutic use</subject><subject>Anti-Inflammatory Agents - therapeutic use</subject><subject>Cardiology</subject><subject>Conjunctivitis, Viral - diagnosis</subject><subject>Conjunctivitis, Viral - drug therapy</subject><subject>Conjunctivitis, Viral - virology</subject><subject>Dexamethasone - therapeutic use</subject><subject>Drug Administration Schedule</subject><subject>Drug Combinations</subject><subject>Endocrinology</subject><subject>Fluorescent Antibody Technique</subject><subject>Health technology assessment</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Oncology</subject><subject>Ophthalmic Solutions</subject><subject>Original Research</subject><subject>Pharmacology/Toxicology</subject><subject>Pilot Projects</subject><subject>Polymerase Chain Reaction</subject><subject>Povidone-Iodine - therapeutic use</subject><subject>Prospective Studies</subject><subject>Rheumatology</subject><subject>Treatment Outcome</subject><issn>0741-238X</issn><issn>1865-8652</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEFP3DAQha2KqizQH8Cl8gVxCozteJ0cEWoBCYlLK3GzHGfCepXYwXYQ_Pt6uyv1xuHJ8vi9N_JHyDmDKwagrhPjgssKoC1a84p9ISvWrGVVxI_IClTNKi6a52NyktIWgIOSzTdyzFol1zWTK_JxQ22YOudNdsHTOby5PnisXOidRwpX9cV1j-9mwrwxKfwbsQsa5k25j5OzNC1pRp92aedp3iDNEU2e0GcaBmp69KU0mrEs8tvF2-zeXHbpjHwdzJjw--E8JX9-_fx9e189Pt093N48VraGNlcW0BjZNQ2THQreDq3iVnRSyM6Idd8BYAeSCeSoYBBq6PtmaBq0UoERphWn5HLfO8fwumDKenLJ4jgaj2FJWomac-Bs52R7p40hpYiDnqObTPzQDPQOuN4D1wW43gHXrGR-HNqXbsL-f-JAuBj43pDKk3_BqLdhib78-JPWv3UojSo</recordid><startdate>20090801</startdate><enddate>20090801</enddate><creator>Pelletier, J. S.</creator><creator>Stewart, K.</creator><creator>Trattler, W.</creator><creator>Ritterband, D. C.</creator><creator>Braverman, S.</creator><creator>Samson, C. M.</creator><creator>Liang, B.</creator><creator>Capriotti, J. A.</creator><general>Springer Healthcare Communications</general><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>20090801</creationdate><title>A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis</title><author>Pelletier, J. S. ; Stewart, K. ; Trattler, W. ; Ritterband, D. C. ; Braverman, S. ; Samson, C. M. ; Liang, B. ; Capriotti, J. A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-c0eaa5b8815be329f972c3b535ba36db00eb0513e2e70f37fdd8f88ec570a3a93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Acute Disease</topic><topic>Adenovirus Infections, Human - diagnosis</topic><topic>Adenovirus Infections, Human - drug therapy</topic><topic>Adenovirus Infections, Human - virology</topic><topic>Anti-Infective Agents, Local - therapeutic use</topic><topic>Anti-Inflammatory Agents - therapeutic use</topic><topic>Cardiology</topic><topic>Conjunctivitis, Viral - diagnosis</topic><topic>Conjunctivitis, Viral - drug therapy</topic><topic>Conjunctivitis, Viral - virology</topic><topic>Dexamethasone - therapeutic use</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Endocrinology</topic><topic>Fluorescent Antibody Technique</topic><topic>Health technology assessment</topic><topic>Humans</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Oncology</topic><topic>Ophthalmic Solutions</topic><topic>Original Research</topic><topic>Pharmacology/Toxicology</topic><topic>Pilot Projects</topic><topic>Polymerase Chain Reaction</topic><topic>Povidone-Iodine - therapeutic use</topic><topic>Prospective Studies</topic><topic>Rheumatology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pelletier, J. S.</creatorcontrib><creatorcontrib>Stewart, K.</creatorcontrib><creatorcontrib>Trattler, W.</creatorcontrib><creatorcontrib>Ritterband, D. C.</creatorcontrib><creatorcontrib>Braverman, S.</creatorcontrib><creatorcontrib>Samson, C. M.</creatorcontrib><creatorcontrib>Liang, B.</creatorcontrib><creatorcontrib>Capriotti, J. A.</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>Advances in therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pelletier, J. S.</au><au>Stewart, K.</au><au>Trattler, W.</au><au>Ritterband, D. C.</au><au>Braverman, S.</au><au>Samson, C. M.</au><au>Liang, B.</au><au>Capriotti, J. A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis</atitle><jtitle>Advances in therapy</jtitle><stitle>Adv Therapy</stitle><addtitle>Adv Ther</addtitle><date>2009-08-01</date><risdate>2009</risdate><volume>26</volume><issue>8</issue><spage>776</spage><epage>783</epage><pages>776-783</pages><issn>0741-238X</issn><eissn>1865-8652</eissn><abstract>Introduction
The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis.
Methods
A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector™ were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA.
Results
A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to follow-up.
Conclusions
An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted.</abstract><cop>Heidelberg</cop><pub>Springer Healthcare Communications</pub><pmid>19756415</pmid><doi>10.1007/s12325-009-0062-1</doi><tpages>8</tpages></addata></record> |
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subjects | Acute Disease Adenovirus Infections, Human - diagnosis Adenovirus Infections, Human - drug therapy Adenovirus Infections, Human - virology Anti-Infective Agents, Local - therapeutic use Anti-Inflammatory Agents - therapeutic use Cardiology Conjunctivitis, Viral - diagnosis Conjunctivitis, Viral - drug therapy Conjunctivitis, Viral - virology Dexamethasone - therapeutic use Drug Administration Schedule Drug Combinations Endocrinology Fluorescent Antibody Technique Health technology assessment Humans Internal Medicine Medicine Medicine & Public Health Oncology Ophthalmic Solutions Original Research Pharmacology/Toxicology Pilot Projects Polymerase Chain Reaction Povidone-Iodine - therapeutic use Prospective Studies Rheumatology Treatment Outcome |
title | A combination povidone-iodine 0.4%/dexamethasone 0.1% ophthalmic suspension in the treatment of adenoviral conjunctivitis |
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