BACKGROUND: Most of the eye drops currently used replace only the aqueous phase of the tear film. But, due to the fact that, with approximately 80 % of the patients with a dry eye, a disturbance of the lipid phase is present, an approach for new treatment methods needed to be found. We examined a new therapy concept with an eye spray containing liposomes for the therapy of the "dry eye" in a long-term study. GOAL: An examination of the effectiveness of a liposome eye spray (TEARS AGAIN, Optima Pharmaceutical GmbH, Germany) in patients with "dry eye" compared with a spray containing a balanced salt solution was carried out. METHODS: Between August 2003 and May 2004 a double-blind study with 382 patients was accomplished. The treatment group (V; n = 191) was compared with the control group (K; n = 191) for a period of 6 months regarding the following examination criteria: eyelid edge parallel conjunctival folds (LIPCOF), BREAK UP time (BUT), Schirmer I test, best corrected visual acuity, as well as slit lamp findings of the cornea and conjunctiva. Follow-up was after 4 weeks and 6 months. The statistical analysis was performed with the statistical program SPSS v.11.5. RESULTS: The examined parameters such as LIPCOF, BUT and Schirmer were significantly better in the treatment group than in the control group. We found likewise significant improvements of the inflammations of the edge of eyelid with a remarkable decrease of around 89.5 %. Questioning of the patients resulted in, among other things, the belief that the liposome eye spray led altogether to a clear subjective improvement of the symptoms in 72 % of the cases, although an initial burning sensation was mentioned after the application. All patients were of the opinion that application with a spray is more favourably and more pleasant than teardrops. CONCLUSION: The liposome tear substitute shows statistically significant advantages against a balanced salt solution. This new liposome eye spray represents a new, revolutionary and effective procedure in the therapy of the "dry eye". Considering the disturbance of the lipid phase in 80 % of the patients, TEARS AGAIN ought to be a first choice treatment.
RCT Entities:
BACKGROUND: Most of the eye drops currently used replace only the aqueous phase of the tear film. But, due to the fact that, with approximately 80 % of the patients with a dry eye, a disturbance of the lipid phase is present, an approach for new treatment methods needed to be found. We examined a new therapy concept with an eye spray containing liposomes for the therapy of the "dry eye" in a long-term study. GOAL: An examination of the effectiveness of a liposome eye spray (TEARS AGAIN, Optima Pharmaceutical GmbH, Germany) in patients with "dry eye" compared with a spray containing a balanced salt solution was carried out. METHODS: Between August 2003 and May 2004 a double-blind study with 382 patients was accomplished. The treatment group (V; n = 191) was compared with the control group (K; n = 191) for a period of 6 months regarding the following examination criteria: eyelid edge parallel conjunctival folds (LIPCOF), BREAK UP time (BUT), Schirmer I test, best corrected visual acuity, as well as slit lamp findings of the cornea and conjunctiva. Follow-up was after 4 weeks and 6 months. The statistical analysis was performed with the statistical program SPSS v.11.5. RESULTS: The examined parameters such as LIPCOF, BUT and Schirmer were significantly better in the treatment group than in the control group. We found likewise significant improvements of the inflammations of the edge of eyelid with a remarkable decrease of around 89.5 %. Questioning of the patients resulted in, among other things, the belief that the liposome eye spray led altogether to a clear subjective improvement of the symptoms in 72 % of the cases, although an initial burning sensation was mentioned after the application. All patients were of the opinion that application with a spray is more favourably and more pleasant than teardrops. CONCLUSION: The liposome tear substitute shows statistically significant advantages against a balanced salt solution. This new liposome eye spray represents a new, revolutionary and effective procedure in the therapy of the "dry eye". Considering the disturbance of the lipid phase in 80 % of the patients, TEARS AGAIN ought to be a first choice treatment.