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Jim P. Owen; Global RevitaLens Experience and Acceptance Trial (GREAT Trial). Invest. Ophthalmol. Vis. Sci. 2012;53(14):4720.
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To assess the ocular safety, efficacy, patient acceptance and physician recommendation of RevitaLens OcuTec® (in Europe COMPLETE® RevitaLens) Multipurpose Disinfecting Solution (MPDS) in patients currently wearing soft contact lenses and using a MPDS for lens care.
This study is a multi-center, open-label, non-comparative study. 2979 patients from individual sites in Europe and US were recruited for the study. Inclusion criteria were 1) patients wearing soft contact lenses for 12M or more 2) patients wearing same CL brand, fit and correction for at least 6M and 3) patients using MPDS for CL care. Exclusion criteria were 1) patients that did not fit the inclusion criteria or 2) patients using a peroxide cleaning system or Complete® MPS. All patients underwent clinical examination based on the physician’s standard clinical practice. The physician also recorded the severity of signs (ocular redness) and symptoms (burning, irritation, and discomfort) at the initial baseline and final visits. A series of questions regarding patients current MPDS/MPS were recorded at the initial and final visits. After the trial was completed the physician’s overall impression of the RevitaLens OcuTec® MPDS was obtained.
The mean ± SD age of patients was 35.9 ± 13.2 yrs and the mean ± SD treatment days were 37.5 ± 18.06 days. 25.4% of patients had astigmatism, 74.8% of them wore silicone hydrogel CL and 25.2% wore conventional hydrogel CL. There was a significant improvement in the severity of the patients signs and symptoms after using RevitaLens OcuTec® MPDS (paired t-test, p<0.001). 93.5% found RevitaLens OcuTec® MPDS was effective in keeping their contact lens clean. 90.2% found RevitaLens OcuTec® MPDS was effective in keeping their CL feeling comfortable. 87.3% of patients said they would use RevitaLens OcuTec® MPDS in the future. 76.2% of patients surveyed preferred RevitaLens OcuTec® MPDS over their previous MPDS. 87% of doctors surveyed recommend RevitaLens OcuTec® MPDS.
Statistically significant clinical differences were observed in the ocular signs and symptoms after using RevitaLens OcuTec® MPDS. A low rate of adverse events, a high level of patient satisfaction and physician recommendation demonstrates that RevitaLens OcuTec® MPDS is safe and efficacious.
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