Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial
ABSTRACT Purpose: To compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa*) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox*) and 0.1% dexamethasone (Maxidex*) for the prevention of infection and control of inflammation a...
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| Veröffentlicht in: | Current medical research and opinion 2007-12, Vol.23 (12), p.3123-3130 |
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| creator | Lemes Freitas, Lincoln Soriano, Eduardo Muccioli, Cristina Luisa Höfling-Lima, Ana Belfort, Rubens |
| description | ABSTRACT
Purpose: To compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa*) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox*) and 0.1% dexamethasone (Maxidex*) for the prevention of infection and control of inflammation after cataract surgery.
Setting: The ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil.
Methods: A prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days –2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up.
Results: There was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had ≤ 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups ( p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery.
Conclusion: Treatment with the combined moxifloxacin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation. |
| doi_str_mv | 10.1185/030079907X242629 |
| format | Article |
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Purpose: To compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa*) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox*) and 0.1% dexamethasone (Maxidex*) for the prevention of infection and control of inflammation after cataract surgery.
Setting: The ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil.
Methods: A prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days –2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up.
Results: There was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had ≤ 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups ( p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery.
Conclusion: Treatment with the combined moxifloxacin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation.</description><identifier>ISSN: 0300-7995</identifier><identifier>EISSN: 1473-4877</identifier><identifier>DOI: 10.1185/030079907X242629</identifier><identifier>PMID: 17980093</identifier><identifier>CODEN: CMROCX</identifier><language>eng</language><publisher>England: Informa UK Ltd</publisher><subject>Aged ; Anti-Infective Agents - adverse effects ; Anti-Infective Agents - therapeutic use ; Antineoplastic Agents, Hormonal - adverse effects ; Antineoplastic Agents, Hormonal - therapeutic use ; Aza Compounds - adverse effects ; Aza Compounds - therapeutic use ; Cataract extraction ; Dexamethasone ; Dexamethasone - adverse effects ; Dexamethasone - therapeutic use ; Double-Blind Method ; Drug Combinations ; Female ; Fluoroquinolones ; Humans ; Inflammation - drug therapy ; Inflammation - etiology ; Inflammation - prevention & control ; Lens Implantation, Intraocular - adverse effects ; Male ; Middle Aged ; Moxifloxacin ; No-Observed-Adverse-Effect Level ; Phacoemulsification ; Phacoemulsification - adverse effects ; Postoperative Complications - drug therapy ; Postoperative Complications - prevention & control ; Quinolines - adverse effects ; Quinolines - therapeutic use</subject><ispartof>Current medical research and opinion, 2007-12, Vol.23 (12), p.3123-3130</ispartof><rights>2007 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted 2007</rights><rights>Copyright Librapharm Dec 2007</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c427t-5d5ac0f8b06854beab5ba08becd0ed764d71316d7edb8e668c2031aefc0ad7043</citedby><cites>FETCH-LOGICAL-c427t-5d5ac0f8b06854beab5ba08becd0ed764d71316d7edb8e668c2031aefc0ad7043</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.tandfonline.com/doi/pdf/10.1185/030079907X242629$$EPDF$$P50$$Ginformahealthcare$$H</linktopdf><linktohtml>$$Uhttps://www.tandfonline.com/doi/full/10.1185/030079907X242629$$EHTML$$P50$$Ginformahealthcare$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,59647,59753,60436,60542,61221,61256,61402,61437</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17980093$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lemes Freitas, Lincoln</creatorcontrib><creatorcontrib>Soriano, Eduardo</creatorcontrib><creatorcontrib>Muccioli, Cristina</creatorcontrib><creatorcontrib>Luisa Höfling-Lima, Ana</creatorcontrib><creatorcontrib>Belfort, Rubens</creatorcontrib><title>Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial</title><title>Current medical research and opinion</title><addtitle>Curr Med Res Opin</addtitle><description>ABSTRACT
Purpose: To compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa*) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox*) and 0.1% dexamethasone (Maxidex*) for the prevention of infection and control of inflammation after cataract surgery.
Setting: The ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil.
Methods: A prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days –2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up.
Results: There was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had ≤ 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups ( p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery.
Conclusion: Treatment with the combined moxifloxacin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation.</description><subject>Aged</subject><subject>Anti-Infective Agents - adverse effects</subject><subject>Anti-Infective Agents - therapeutic use</subject><subject>Antineoplastic Agents, Hormonal - adverse effects</subject><subject>Antineoplastic Agents, Hormonal - therapeutic use</subject><subject>Aza Compounds - adverse effects</subject><subject>Aza Compounds - therapeutic use</subject><subject>Cataract extraction</subject><subject>Dexamethasone</subject><subject>Dexamethasone - adverse effects</subject><subject>Dexamethasone - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Fluoroquinolones</subject><subject>Humans</subject><subject>Inflammation - drug therapy</subject><subject>Inflammation - etiology</subject><subject>Inflammation - prevention & control</subject><subject>Lens Implantation, Intraocular - adverse effects</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Moxifloxacin</subject><subject>No-Observed-Adverse-Effect Level</subject><subject>Phacoemulsification</subject><subject>Phacoemulsification - adverse effects</subject><subject>Postoperative Complications - drug therapy</subject><subject>Postoperative Complications - prevention & control</subject><subject>Quinolines - adverse effects</subject><subject>Quinolines - therapeutic use</subject><issn>0300-7995</issn><issn>1473-4877</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kUtv1TAQhSMEoreFPStksSbUzstOWaGqBaRKbEBiF43tsa6LEwc7gZt_yM_CublSBRKs_Jhzvhn7ZNkLRt8wJupLWlLK25byr0VVNEX7KNuxipd5JTh_nO3Wcp7q9Vl2HuM9pawQbfs0O2O8FZS25S77dWOMVaAWAoMmk3cYQFpnp4V4Q4Ao30s7oCa9P1jj_AGUHS41HqDHaQ_RD0iMD_3sYLJ-WPeJMiakI2Pw435xcLDxSA-oZ3VUJbQdjIO-31x2IOMelMfEiXYdaL2-2vqPENLxB74m2s_SIekhfksTKWeHY58pWHDPsicGXMTnp_Ui-3J78_n6Q3736f3H63d3uaoKPuW1rkFRIyRtRF1JBFlLoEKi0hQ1byrNWckazVFLgU0jVEFLBmgUBc1pVV5krzZuet33GePU3fs5DKllV6xZsEq0SUQ3kQo-xoCmG4PtISwdo92aXPd3csny8sSdZY_6wXCKKgneboL0c-nD4acPTncTLM4HE2BQNnblf_BXf7j3CG7aKwj4MP8_zb8BOMjASQ</recordid><startdate>20071201</startdate><enddate>20071201</enddate><creator>Lemes Freitas, Lincoln</creator><creator>Soriano, Eduardo</creator><creator>Muccioli, Cristina</creator><creator>Luisa Höfling-Lima, Ana</creator><creator>Belfort, Rubens</creator><general>Informa UK Ltd</general><general>Taylor & Francis</general><general>Informa Healthcare</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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>S0X</scope></search><sort><creationdate>20071201</creationdate><title>Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial</title><author>Lemes Freitas, Lincoln ; 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Purpose: To compare the efficacy and safety of a combined 0.5% moxifloxacin and 0.1% dexamethasone formulation (Vigadexa*) versus conventional dosing with 0.5% concomitant moxifloxacin (Vigamox*) and 0.1% dexamethasone (Maxidex*) for the prevention of infection and control of inflammation after cataract surgery.
Setting: The ophthalmology clinic and outpatient surgery suite of a public hospital in Brazil.
Methods: A prospective, randomized, double-masked, parallel-group study of 139 patients, all of which underwent phacoemulsification and intraocular lens (IOL) implantation. After random assignment, 64 eyes received the combination of topical 0.5% moxifloxacin/0.1% dexamethasone drop and 62 eyes received 0.5% moxifloxacin and 0.1% dexamethasone as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on surgery days –2, 1, 3, 8, and 15. Limitations of this study included its small size and relatively short duration of follow-up.
Results: There was no sign of intraocular infection at any time and only minimal inflammation beyond day 3. Physicians rated bacterial infection to be absent in both groups on days 1, 3, 8 and 15. Ninety-seven percent of patients in each group had ≤ 5 cells by day 15. Objective and subjective parameters were essentially the same in both treatment groups ( p > 0.05). One patient in the conventional therapy group developed viral conjunctivitis unrelated to the surgery.
Conclusion: Treatment with the combined moxifloxacin/dexamethasone eye drops was as effective as conventional treatment in preventing infection and controlling inflammation after phacoemulsification and IOL implantation.</abstract><cop>England</cop><pub>Informa UK Ltd</pub><pmid>17980093</pmid><doi>10.1185/030079907X242629</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0300-7995 |
| ispartof | Current medical research and opinion, 2007-12, Vol.23 (12), p.3123-3130 |
| issn | 0300-7995 1473-4877 |
| language | eng |
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| source | MEDLINE; Taylor & Francis:Master (3349 titles); Taylor & Francis Medical Library - CRKN |
| subjects | Aged Anti-Infective Agents - adverse effects Anti-Infective Agents - therapeutic use Antineoplastic Agents, Hormonal - adverse effects Antineoplastic Agents, Hormonal - therapeutic use Aza Compounds - adverse effects Aza Compounds - therapeutic use Cataract extraction Dexamethasone Dexamethasone - adverse effects Dexamethasone - therapeutic use Double-Blind Method Drug Combinations Female Fluoroquinolones Humans Inflammation - drug therapy Inflammation - etiology Inflammation - prevention & control Lens Implantation, Intraocular - adverse effects Male Middle Aged Moxifloxacin No-Observed-Adverse-Effect Level Phacoemulsification Phacoemulsification - adverse effects Postoperative Complications - drug therapy Postoperative Complications - prevention & control Quinolines - adverse effects Quinolines - therapeutic use |
| title | Efficacy and tolerability of a combined moxifloxacin/dexamethasone formulation for topical prophylaxis and reduction of inflammation in phacoemulsification: a comparative, double masked clinical trial |
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