S Hitoe1, J Tanaka, H Shimoda. 1. Research and Development Division, Oryza Oil & Fat Chemical Co., Ltd., Ichinomiya, Aichi, Japan - kaihatsu@mri.biglobe.ne.jp.
Abstract
AIM: Dry eye symptoms, resulting from insufficient tear fluid generation, represent a considerable burden for a largely underestimated number of people. We concluded from earlier pre-clinical investigations that the etiology of dry eyes encompasses oxidative stress burden to lachrymal glands and that antioxidant MaquiBright™ Aristotelia chilensis berry extract helps restore glandular activity. METHODS: In this pilot trial we investigated 13 healthy volunteers with moderately dry eyes using Schirmer test, as well as a questionnaire which allows for estimating the impact of dry eyes on daily routines. Study participants were assigned to one of two groups, receiving MaquiBright™ at daily dosage of either 30 mg (N.=7) or 60 mg (N.=6) over a period of 60 days. Both groups presented with significantly (P<0.05) improved tear fluid volume already after 30 days treatment. Schirmer test showed an increase from baseline 16.3±2.6 mm to 24.4±4.8 mm (P<0.05) with 30 mg MaquiBright™ and from 18.7±1.9 mm to 27.6±3.4 mm with 60 mg (P<0.05), respectively. Following treatment with 30 mg MaquiBright™ for further 30 days, tear fluid volume dropped slightly to 20.5±2.8 mm, whereas the improvement persisted with 60 mg treatment at 27.1±2.7 mm after 60 days treatment (P<0.05 vs. baseline). RESULTS: The burden of eye dryness on daily routines was evaluated employing the "Dry Eye-related Quality of life Score" (DEQS), with values spanning from zero (impact) to a maximum score of 60. Participants had comparable baseline values of 41.0±7.7 (30 mg) and 40.2±6.3 (60 mg). With 30 mg treatment the score significantly decreased to 21.8±3.9 and 18.9±3.9, after 30 and 60 days, respectively. With 60 mg treatment the DEQS significantly decreased to 26.9±5.3 and 11.1±2.7, after 30 and 60 days, respectively. Blood was drawn for safety analyses (complete blood rheology and -chemistry) at all three investigative time points without negative findings. CONCLUSION: In conclusion, while daily supplementation with 30 mg MaquiBright™ is effective, the dosage of 60 significantly increased tear fluid volume at all investigative time points and decreased dry eye symptoms to almost a quarter from initial values after two months treatment.
RCT Entities:
AIM: Dry eye symptoms, resulting from insufficient tear fluid generation, represent a considerable burden for a largely underestimated number of people. We concluded from earlier pre-clinical investigations that the etiology of dry eyes encompasses oxidative stress burden to lachrymal glands and that antioxidant MaquiBright™ Aristotelia chilensis berry extract helps restore glandular activity. METHODS: In this pilot trial we investigated 13 healthy volunteers with moderately dry eyes using Schirmer test, as well as a questionnaire which allows for estimating the impact of dry eyes on daily routines. Study participants were assigned to one of two groups, receiving MaquiBright™ at daily dosage of either 30 mg (N.=7) or 60 mg (N.=6) over a period of 60 days. Both groups presented with significantly (P<0.05) improved tear fluid volume already after 30 days treatment. Schirmer test showed an increase from baseline 16.3±2.6 mm to 24.4±4.8 mm (P<0.05) with 30 mg MaquiBright™ and from 18.7±1.9 mm to 27.6±3.4 mm with 60 mg (P<0.05), respectively. Following treatment with 30 mg MaquiBright™ for further 30 days, tear fluid volume dropped slightly to 20.5±2.8 mm, whereas the improvement persisted with 60 mg treatment at 27.1±2.7 mm after 60 days treatment (P<0.05 vs. baseline). RESULTS: The burden of eye dryness on daily routines was evaluated employing the "Dry Eye-related Quality of life Score" (DEQS), with values spanning from zero (impact) to a maximum score of 60. Participants had comparable baseline values of 41.0±7.7 (30 mg) and 40.2±6.3 (60 mg). With 30 mg treatment the score significantly decreased to 21.8±3.9 and 18.9±3.9, after 30 and 60 days, respectively. With 60 mg treatment the DEQS significantly decreased to 26.9±5.3 and 11.1±2.7, after 30 and 60 days, respectively. Blood was drawn for safety analyses (complete blood rheology and -chemistry) at all three investigative time points without negative findings. CONCLUSION: In conclusion, while daily supplementation with 30 mg MaquiBright™ is effective, the dosage of 60 significantly increased tear fluid volume at all investigative time points and decreased dry eye symptoms to almost a quarter from initial values after two months treatment.