PURPOSE: To evaluate the effect of three different liposomal eye sprays on ocular comfort and tear film stability. METHODS: OptrexActiMist (AM, Optima-Pharma, Germany) was applied onto one, randomly selected eye of 80 subjects (female=49; mean age=49 years±18.6 SD) in a multi-centred, double-masked study. DryEyesMist (DEM, Boots) or TearMist (TM, Tesco) was applied onto the contralateral eye in randomized order. Over-all symptoms were investigated using the Ocular Surface Disease Index (OSDI). Ocular comfort (visual-analogue scale 0-100 [100=perfect]) and non-invasive tear film stability (NIBUT) of each eye was evaluated before application (randomized order) and were again measured 10 min after application. Effects of products on ocular comfort and NIBUT were calculated as "factor" (=after-treatment/before-treatment). Differences between measurements were analysed by ANOVA repeated measurements and differences between groups by the dependent t-test (or the non-parametric equivalent). RESULTS:OSDI-scores (mean=8.1±9.0 SD), comfort (65±24) and NIBUT (12 s±12.3) were statistically similar between centres (p>0.400). Comfort and NIBUT were not different (p>0.14) between product groups before application. Comfort and NIBUT improved significantly after application of AM (p<0.001) but worsened with the comparing products (p<0.058). Comfort improved by a mean factor of 1.5 (±0.82 SD) after application of AM but decreased after application of the comparing products (DEM: 0.9±0.33; TM: 0.9±0.34). Both factors were significantly better in AM (p<0.027). CONCLUSION: The original liposomal eye-spray 'OptrexActiMist' significantly improved ocular comfort and tear film stability while 'TearMist' or 'DryEyesMist' worsened both criteria. The latter two products may not be clinically effective in the treatment of dry eye.
RCT Entities:
PURPOSE: To evaluate the effect of three different liposomal eye sprays on ocular comfort and tear film stability. METHODS: OptrexActiMist (AM, Optima-Pharma, Germany) was applied onto one, randomly selected eye of 80 subjects (female=49; mean age=49 years±18.6 SD) in a multi-centred, double-masked study. DryEyesMist (DEM, Boots) or TearMist (TM, Tesco) was applied onto the contralateral eye in randomized order. Over-all symptoms were investigated using the Ocular Surface Disease Index (OSDI). Ocular comfort (visual-analogue scale 0-100 [100=perfect]) and non-invasive tear film stability (NIBUT) of each eye was evaluated before application (randomized order) and were again measured 10 min after application. Effects of products on ocular comfort and NIBUT were calculated as "factor" (=after-treatment/before-treatment). Differences between measurements were analysed by ANOVA repeated measurements and differences between groups by the dependent t-test (or the non-parametric equivalent). RESULTS: OSDI-scores (mean=8.1±9.0 SD), comfort (65±24) and NIBUT (12 s±12.3) were statistically similar between centres (p>0.400). Comfort and NIBUT were not different (p>0.14) between product groups before application. Comfort and NIBUT improved significantly after application of AM (p<0.001) but worsened with the comparing products (p<0.058). Comfort improved by a mean factor of 1.5 (±0.82 SD) after application of AM but decreased after application of the comparing products (DEM: 0.9±0.33; TM: 0.9±0.34). Both factors were significantly better in AM (p<0.027). CONCLUSION: The original liposomal eye-spray 'OptrexActiMist' significantly improved ocular comfort and tear film stability while 'TearMist' or 'DryEyesMist' worsened both criteria. The latter two products may not be clinically effective in the treatment of dry eye.