A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis
To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis. Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration. A total of 135 patients with signs and symptoms of seasonal allergic...
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| Veröffentlicht in: | Ophthalmology (Rochester, Minn.) Minn.), 1999-02, Vol.106 (2), p.362-369 |
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| container_title | Ophthalmology (Rochester, Minn.) |
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| creator | Shulman, David G Lothringer, Larry L Rubin, Jay M Briggs, Richard B Howes, John Novack, Gary D Hart, Kathryn |
| description | To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis.
Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration.
A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated.
All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days.
Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured.
A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE (
P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively).
Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment.
Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo. |
| doi_str_mv | 10.1016/S0161-6420(99)90077-5 |
| format | Article |
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Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration.
A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated.
All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days.
Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured.
A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE (
P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively).
Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment.
Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.</description><identifier>ISSN: 0161-6420</identifier><identifier>EISSN: 1549-4713</identifier><identifier>DOI: 10.1016/S0161-6420(99)90077-5</identifier><identifier>PMID: 9951491</identifier><identifier>CODEN: OPHTDG</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adult ; Aged ; Androstadienes - administration & dosage ; Androstadienes - adverse effects ; Androstadienes - therapeutic use ; Anti-Allergic Agents - administration & dosage ; Anti-Allergic Agents - adverse effects ; Anti-Allergic Agents - therapeutic use ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - adverse effects ; Anti-Inflammatory Agents - therapeutic use ; Biological and medical sciences ; Conjunctivitis, Allergic - drug therapy ; Conjunctivitis, Allergic - physiopathology ; Double-Blind Method ; Female ; Humans ; Intraocular Pressure - drug effects ; Loteprednol Etabonate ; Male ; Medical sciences ; Middle Aged ; Oculomotor disorders ; Ophthalmic Solutions - administration & dosage ; Ophthalmic Solutions - adverse effects ; Ophthalmic Solutions - therapeutic use ; Ophthalmology ; Prospective Studies ; Safety ; Seasons ; Treatment Outcome</subject><ispartof>Ophthalmology (Rochester, Minn.), 1999-02, Vol.106 (2), p.362-369</ispartof><rights>1999 American Academy of Ophthalmology, Inc.</rights><rights>1999 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S0161-6420(99)90077-5$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,777,781,3537,27905,27906,45976</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=1679920$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9951491$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shulman, David G</creatorcontrib><creatorcontrib>Lothringer, Larry L</creatorcontrib><creatorcontrib>Rubin, Jay M</creatorcontrib><creatorcontrib>Briggs, Richard B</creatorcontrib><creatorcontrib>Howes, John</creatorcontrib><creatorcontrib>Novack, Gary D</creatorcontrib><creatorcontrib>Hart, Kathryn</creatorcontrib><title>A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis</title><title>Ophthalmology (Rochester, Minn.)</title><addtitle>Ophthalmology</addtitle><description>To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis.
Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration.
A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated.
All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days.
Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured.
A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE (
P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively).
Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment.
Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.</description><subject>Adult</subject><subject>Aged</subject><subject>Androstadienes - administration & dosage</subject><subject>Androstadienes - adverse effects</subject><subject>Androstadienes - therapeutic use</subject><subject>Anti-Allergic Agents - administration & dosage</subject><subject>Anti-Allergic Agents - adverse effects</subject><subject>Anti-Allergic Agents - therapeutic use</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - adverse effects</subject><subject>Anti-Inflammatory Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Conjunctivitis, Allergic - drug therapy</subject><subject>Conjunctivitis, Allergic - physiopathology</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Intraocular Pressure - drug effects</subject><subject>Loteprednol Etabonate</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Oculomotor disorders</subject><subject>Ophthalmic Solutions - administration & dosage</subject><subject>Ophthalmic Solutions - adverse effects</subject><subject>Ophthalmic Solutions - therapeutic use</subject><subject>Ophthalmology</subject><subject>Prospective Studies</subject><subject>Safety</subject><subject>Seasons</subject><subject>Treatment Outcome</subject><issn>0161-6420</issn><issn>1549-4713</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kd1qVDEUhYModaw-QiEXChU8NT8nyeRKSvEPCl5Ur8M-yR5NzZwckkylfYg-s5l26E12wvpYO3svQk44O-OM649X_eCDHgU7tfa9ZcyYQT0jK65GO4yGy-dk9YS8JK9qvWaMaS3HI3JkreKj5Styf04LzCFv4x2GDzTk3ZRw2EL9u38uCTxOefB5biWnhIEuUKBfEq1tF25p3tCUGy4Fw5wTxQZTnqEhZWfiHY1z51vEuVX6L7Y_tCLUrie69yi_o6fd-no3-xZvYov1NXmxgVTxzaEek19fPv-8-DZc_vj6_eL8ckBheRt8kBZ0EFKxtbAg1sJvGMhglGSjFNoajqDXMAGTjAWlpZFcglEKuJHrSR6Tk0ffZTdtMbilxC2UW3fYS9ffHnSoHtKm78jH-oRxbawVrGOfHjHsf72JWFz1fVqPIRb0zYUcHWdun5d7yMvtw-hd3ENeTsn_hySIIg</recordid><startdate>19990201</startdate><enddate>19990201</enddate><creator>Shulman, David G</creator><creator>Lothringer, Larry L</creator><creator>Rubin, Jay M</creator><creator>Briggs, Richard B</creator><creator>Howes, John</creator><creator>Novack, Gary D</creator><creator>Hart, Kathryn</creator><general>Elsevier Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope></search><sort><creationdate>19990201</creationdate><title>A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis</title><author>Shulman, David G ; Lothringer, Larry L ; Rubin, Jay M ; Briggs, Richard B ; Howes, John ; Novack, Gary D ; Hart, Kathryn</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-e291t-cd39a6d2350829a282cf0a3d75304326971ea68aba0300d5637313a755a1738b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Androstadienes - administration & dosage</topic><topic>Androstadienes - adverse effects</topic><topic>Androstadienes - therapeutic use</topic><topic>Anti-Allergic Agents - administration & dosage</topic><topic>Anti-Allergic Agents - adverse effects</topic><topic>Anti-Allergic Agents - therapeutic use</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - adverse effects</topic><topic>Anti-Inflammatory Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Conjunctivitis, Allergic - drug therapy</topic><topic>Conjunctivitis, Allergic - physiopathology</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Intraocular Pressure - drug effects</topic><topic>Loteprednol Etabonate</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Oculomotor disorders</topic><topic>Ophthalmic Solutions - administration & dosage</topic><topic>Ophthalmic Solutions - adverse effects</topic><topic>Ophthalmic Solutions - therapeutic use</topic><topic>Ophthalmology</topic><topic>Prospective Studies</topic><topic>Safety</topic><topic>Seasons</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shulman, David G</creatorcontrib><creatorcontrib>Lothringer, Larry L</creatorcontrib><creatorcontrib>Rubin, Jay M</creatorcontrib><creatorcontrib>Briggs, Richard B</creatorcontrib><creatorcontrib>Howes, John</creatorcontrib><creatorcontrib>Novack, Gary D</creatorcontrib><creatorcontrib>Hart, Kathryn</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><jtitle>Ophthalmology (Rochester, Minn.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shulman, David G</au><au>Lothringer, Larry L</au><au>Rubin, Jay M</au><au>Briggs, Richard B</au><au>Howes, John</au><au>Novack, Gary D</au><au>Hart, Kathryn</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis</atitle><jtitle>Ophthalmology (Rochester, Minn.)</jtitle><addtitle>Ophthalmology</addtitle><date>1999-02-01</date><risdate>1999</risdate><volume>106</volume><issue>2</issue><spage>362</spage><epage>369</epage><pages>362-369</pages><issn>0161-6420</issn><eissn>1549-4713</eissn><coden>OPHTDG</coden><abstract>To evaluate the effects of loteprednol etabonate (LE) 0.2% in reducing the signs and symptoms of seasonal allergic conjunctivitis.
Randomized, double-masked, placebo-controlled, parallel group multicenter study of 6 weeks duration.
A total of 135 patients with signs and symptoms of seasonal allergic conjunctivitis participated.
All patients received either LE 0.2% or placebo (vehicle) four times a day in both eyes for 42 days.
Bulbar conjunctival injection (primary sign) and itching (primary symptom) over the first 2 weeks of treatment was measured.
A reduction in severity was seen in both LE and placebo groups for bulbar conjunctival injection (1.5 vs. 1.0 units on a 0–3 scale) and itching (3.4 vs. 3.0 units on a 0–4 scale) over the first 2 weeks. The treatment effect by these measures was −0.5 and −0.4 units in favor of LE (
P ≤ 0.008). Resolution (i.e., the proportion of patients with signs or symptoms no longer present) at day 14 strongly favored LE-treated patients (36% and 15%; 58% and 38%, for injection and itching, respectively).
Both treatments were well tolerated. One patient in each treatment group (1 of 67 and 1 of 68, respectively) had an elevation of intraocular pressure of 10 mmHg or greater during the 6 weeks of treatment.
Loteprednol etabonate 0.2% was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate 0.2% had a safety profile comparable to placebo.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>9951491</pmid><doi>10.1016/S0161-6420(99)90077-5</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0161-6420 |
| ispartof | Ophthalmology (Rochester, Minn.), 1999-02, Vol.106 (2), p.362-369 |
| issn | 0161-6420 1549-4713 |
| language | eng |
| recordid | cdi_pubmed_primary_9951491 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Adult Aged Androstadienes - administration & dosage Androstadienes - adverse effects Androstadienes - therapeutic use Anti-Allergic Agents - administration & dosage Anti-Allergic Agents - adverse effects Anti-Allergic Agents - therapeutic use Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - adverse effects Anti-Inflammatory Agents - therapeutic use Biological and medical sciences Conjunctivitis, Allergic - drug therapy Conjunctivitis, Allergic - physiopathology Double-Blind Method Female Humans Intraocular Pressure - drug effects Loteprednol Etabonate Male Medical sciences Middle Aged Oculomotor disorders Ophthalmic Solutions - administration & dosage Ophthalmic Solutions - adverse effects Ophthalmic Solutions - therapeutic use Ophthalmology Prospective Studies Safety Seasons Treatment Outcome |
| title | A randomized, double-masked, placebo-controlled parallel study of loteprednol etabonate 0.2% in patients with seasonal allergic conjunctivitis |
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