By a News Reporter-Staff News Editor at Clinical Trials Week -- Fresh data on Clinical Research are presented in a new report. According to news reporting originating from Baltimore, Maryland, by NewsRx correspondents, research stated, "Theoretically, autologous serum tears (AST) have a potential advantage over traditional therapies based on the assumption that AST serve not only as a lacrimal substitute to provide lubrication, but also contain other biochemical components mimicking natural tears more closely. The application of AST in dry eye treatment has gained popularity as an adjunctive treatment for dry eye."
Our news editors obtained a quote from the research from the Johns Hopkins University Bloomberg School of Public Health, "However, thus far there has been no systematic review assessing the effectiveness of AST in the treatment for dry eye. To assess the safety and effectiveness of AST eye drops compared to artificial tears for treating dry eye. Search methods We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2013, Issue 3), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE, (January 1950 to April 2013), EMBASE (January 1980 to April 2013), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to April 2013), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We also searched the Science Citation Index Expanded database and reference lists of included studies. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 15 April 2013. Selection criteria We included randomized controlled trials (RCTs) in which AST was compared to artificial tears in the treatment of dry eye. Data collection and analysis Two review authors independently screened all retrieved articles. Methodological quality and study characteristics of the included trials were assessed by two review authors. We contacted investigators for missing data. For both primary and secondary outcomes, we reported mean differences with corresponding 95% confidence intervals (CIs) for continuous outcomes. Four eligible trials randomized individuals (n = 72 participants) with dry eye of various etiologies (Sjogren's syndrome-related dry eye, non-Sjogren's syndrome dry eye and postoperative dry eye induced by laser-assisted in situ keratomileusis (LASIK)) to either AST or artificial tear treatment. The quality of the evidence provided by these trials was variable. Incomplete outcome reporting and heterogeneity in the participant populations prevented the inclusion of these trials in a summary meta-analysis. Based on the results of two trials in 32 participants, 20% AST may provide some improvement in participant-reported symptoms compared to traditional artificial tears after two weeks of treatment. One trial also showed promising results with a mean difference in tear break-up time (TBUT) of 2.00 seconds (95% CI 0.99 to 3.01 seconds) between 20% AST and artificial tears after two weeks. These findings in participant-reported symptom improvement and tear film stability were not consistent in the other trials. Based on additional objective clinical assessments, AST was not associated with improvements in aqueous tear production measured by Schirmer's test (two trials, 33 participants), ocular surface condition with fluorescein (four trials, 72 participants) or Rose Bengal staining (three trials, 60 participants), and epithelial metaplasia by impression cytology compared to artificial tears (one trial, 13 participants). Data on adverse effects were not reported consistently in the included studies; however, there were no reported serious adverse events associated with the collection of and treatment with AST. Authors' conclusions Although 20% AST may provide some benefit in improving participant-reported symptoms in the short-term (two weeks), there is still a lack of sufficient and strong evidence to determine whether the application of AST offers a significant advantage over artificial tears on dry eye."
According to the news editors, the research concluded: "Well-planned, large, high-quality RCTs are warranted, comparing different concentrations of AST to artificial tears using standardized questionnaires to measure patient-reported outcomes and objective clinical tests as well as objective biomarkers, to provide a robust and reliable clinical evidence base."
For more information on this research see: Autologous serum eye drops for dry eye. Cochrane Database of Systematic Reviews, 2013;(8):2002-2031. Cochrane Database of Systematic Reviews can be contacted at: Wiley-Blackwell, 111 River St, Hoboken 07030-5774, NJ, USA (see also Clinical Research).
The news editors report that additional information may be obtained by contacting Q. Pan, Johns Hopkins Bloomberg Sch Public Hlth, Dept. of Epidemiol, Baltimore, MD, United States. Additional authors for this research include A. Angelina, A. Zambrano, M. Marrone, W.J. Stark, T. Heflin, L. Tang and E.K. Akpek.
Keywords for this news article include: Therapy, Maryland, Baltimore, Treatment, United States, Clinical Research, Adverse Drug Reaction, North and Central America, Clinical Trials and Studies
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