Document Detail


Clinical experience with Tilavist: an overview of efficacy and safety.
MedLine Citation:
PMID:  7785746     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A programme of clinical studies was carried out to determine the basic efficacy and safety of 2% nedocromil sodium eye drops (Tilavist) in treating allergic conjunctivitis, in 2,905 patients from 3-76 years of age. Results of all the double-masked placebo comparative studies completed to date-five in vernal keratoconjunctivitis (VKC), five in perennial (PAC) and 16 in seasonal allergic conjunctivitis (SAC)-have been assessed in a statistical overview analysis. Nedocromil sodium, administered four times daily to 153 patients with VKC, was significantly more effective than placebo (155 patients) and in the clinicians' opinion gave good control in 76% of cases, compared with 46% for placebo (p < 0.001). Patients with chronic symptoms of PAC also responded better to nedocromil sodium given four times daily (n = 146) rather than twice daily (n = 86), and significantly more patients (p < 0.001) were effectively controlled by four times daily treatment with nedocromil sodium (72%) than with placebo (47%; n = 156). Twice-daily dosage with nedocromil sodium (n = 677) was adequate for SAC, however, and the treatment was statistically better than placebo (p < 0.01-p < 0.001) whether dosed twice or four times daily. Speed of action was assessed in seven SAC studies in which 79% of all patients (n = 295) using nedocromil sodium had experienced relief of symptoms when questioned, half of them within 15 minutes and 74% during the first hour after dosing. Test treatments were well-accepted by both adults and children, and there were no major adverse events. Minor irritations reported more frequently with nedocromil sodium than placebo were stinging or burning of the eyes on application of the drops and a distinctive taste, noted by 5% of the active treatment group (n = 1,552).
Authors:
N I Kjellman; M T Stevens
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Publication Detail:
Type:  Comparative Study; Journal Article; Review    
Journal Detail:
Title:  Allergy     Volume:  50     ISSN:  0105-4538     ISO Abbreviation:  Allergy     Publication Date:  1995  
Date Detail:
Created Date:  1995-07-14     Completed Date:  1995-07-14     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7804028     Medline TA:  Allergy     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  14-22; discussion 34-8     Citation Subset:  IM    
Affiliation:
University Hospital, Linköping, Sweden.
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adolescent
Adult
Aged
Child
Child, Preschool
Clinical Trials as Topic
Conjunctiva / drug effects
Conjunctivitis, Allergic / drug therapy*,  physiopathology
Double-Blind Method
Drug Administration Schedule
Drug Tolerance
Humans
Middle Aged
Nedocromil / administration & dosage,  adverse effects,  therapeutic use*
Ophthalmic Solutions
Randomized Controlled Trials as Topic
Chemical
Reg. No./Substance:
0/Ophthalmic Solutions; 69049-73-6/Nedocromil

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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