Artikel
A new therapy concept with a liposome eye spray for the therapy of the "dry eye": First clinical results of a statistical analysis of a long-term study
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Veröffentlicht: | 22. September 2004 |
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Gliederung
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Objective
Most used eye drops replace only the aqueous phase of the tear film. Their effectiveness is judged differently. We examined a new therapy concept with a eye spray, containing liposomes for the therapy of the "dry eye" in a long-term study. Goal of our study was the examination of the effectiveness of a liposome eye spray (Tears again®, Optima Pharmaceutical GmbH, Germany) at patients with "dry eye" compared with a spray containing balanced salt solution.
Methods
Since August 2003 a double-blind study with 382 patients was accomplished. The experimental group (V; n=191) was analyzed with the control's group (K; n=191) for a period of 6 months regarding the following criteria examines: Eyelid edge parallel conjunctivale folds (LIPCOF), BREAK UP time (BUT), Schirmer I, corrected visual acuity, as well as slit-lamp findings of cornea and conjunctiva. Altogether 135 parameters were analyzed. Follow-up was after 4 weeks and 6 months. The statistic analysis was performed with the statistical program SPSS v.11.5.
Results
The examined parameters such as LIPCOF, BUT, Schirmer and Visus were significantly better in the experimental group than in the control's group. We found likewise significant improvements, among other things, with blepharitis and conjunctivitis. The questioning of the patients resulted in, among other things, that the liposome eye spray led altogether to a clear subjective improvement of the symptoms in 72% of the cases, although initial burning was indicated after the application. All patients were of the opinion, that application with a spray is more favourably and more pleasantly than as teardrops.
Conclusions
The liposome tear substitute shows statistically significant advantages opposite balanced saline solution. Due to the fact that with approximately 78% of the patients with a dry eye a disturbance of the lipid phase is present, the liposome eye spray represents a new and effective procedure in the therapy of the "dry eye".