Dataset Information

Safety and efficacy of wiping lid margins with lid hygiene shampoo using the "eye brush", a novel lid hygiene item, in healthy subjects: a pilot study.

ABSTRACT: BACKGROUND:To evaluate the safety and efficacy of using a lid hygiene brush prototype to wipe the lid margins with lid hygiene shampoo in subjects with normal meibomian glands. METHODS:Twelve eyes of 6 subjects were all evaluated just before and after wiping lid margins using 1) tap water alone, 2) Eye Shampoo, 3) Eye Brush, or 4) both products, each during a different week. The results after using both products twice daily for 1?month were also evaluated. Wiping efficacy was determined by post-wiping scores for the remaining fluorescein-stained 0.3% Tarivid ointment fully applied to eyelids and lid margins under microscopic view illuminated by blue light just after performing each of the four lid hygiene methods described above. RESULTS:No significant deterioration in ocular conditions occurred. Eyestrain, eye discharge, and dryness decreased with tap water (P?=?0.020), Eye Shampoo (P?=?0.036), and Eye Brush (P?=?0.014), respectively. Sensations of eye discharge increased after 1?month of using both products (P?=?0.042). The wiping efficacy of Eye Brush, Eye Shampoo or both was significantly greater than that of tap water alone (two-sided test, P?=?0.003, 0.003, 0.002), and using both significantly increased efficacy above Eye Shampoo use alone (one-sided test, P?=?0.009). CONCLUSIONS:Wiping lid margins using Eye Brush enhanced the cleansing power of Eye Shampoo. A daily healthcare routine using both products could be a safe and effective option for daily lid hygiene. TRIAL REGISTRATION:UMIN000016905 . Registration date: March 24, 2015; the study was prospectively registered.

SUBMITTER: Tanabe H

PROVIDER: S-EPMC6360667 | biostudies-other | 2019 Feb

REPOSITORIES: biostudies-other

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Safety and efficacy of wiping lid margins with lid hygiene shampoo using the "eye brush", a novel lid hygiene item, in healthy subjects: a pilot study.

Tanabe Hirotaka H Kawashima Motoko M Kaido Minako M Ishida Reiko R Kawakita Tetsuya T Tsubota Kazuo K

BMC ophthalmology 20190204 1

<h4>Background</h4>To evaluate the safety and efficacy of using a lid hygiene brush prototype to wipe the lid margins with lid hygiene shampoo in subjects with normal meibomian glands.<h4>Methods</h4>Twelve eyes of 6 subjects were all evaluated just before and after wiping lid margins using 1) tap water alone, 2) Eye Shampoo, 3) Eye Brush, or 4) both products, each during a different week. The results after using both products twice daily for 1 month were also evaluated. Wiping efficacy was dete ...[more]

PMID: 30717687

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Project description:RationaleLysergic acid diethylamide (LSD) is used in psychiatric and psychological research and investigated as a potential treatment for medical and psychiatric disorders, including depression, anxiety, and cluster headache.ObjectivesSafety data on clinical safety are available from small studies but not from larger samples. We report safety pharmacology data from a large pooled study sample on acute effects of LSD in healthy subjects.MethodsWe conducted a pooled analysis of four double-blind, randomized, placebo-controlled, crossover studies that included a total of 83 healthy subjects and 131 single-dose administrations of LSD. LSD administrations were matched to dose groups according to measured LSD peak plasma concentrations to adjust for uncertainties in the correct LSD dose in some studies. Single doses were 25, 50, 100, and 200 µg of LSD base. We investigated subjective effects (self-rated any drug effect, good drug effect, bad drug effect, and anxiety), blood pressure, heart rate, body temperature, duration of the acute LSD response, acute (12 h) and subacute (24 h) adverse effects, reports of flashbacks, and liver and kidney function before and after the studies.ResultsLSD dose-dependently increased subjective, physiologic, and adverse effects. The dose-response curves for the proportions of subjects with a certain amount of a subjective effect were steeper and reached a higher maximum for positive acute subjective effects compared with negative acute subjective effects. Maximal ratings of > 50% good drug effects were reached in 37%, 91%, 96%, and 91% of the LSD administrations at 25, 50, 100, and 200 µg. Maximal ratings of > 50% bad drug effects were reached in 0%, 9%, 27%, 31% at 25, 50, 100, and 200 µg, respectively. Mean ratings of Oceanic Boundlessness were 10%, 25%, 41%, and 44%, and mean ratings of Anxious Ego-Dissolution were 3.4%, 13%, 20%, and 22% at 25, 50, 100, and 200 µg, respectively. The physiologic effects of LSD were moderate. None of the subjects had systolic blood pressure > 180 mmHg at any time. Peak heart rate > 100 beats/min was observed in 0%, 6%, 20%, and 25% of the subjects at 25, 50, 100, and 200 µg, respectively. Maximal heart rates of 129 and 121 beats/min were observed in one subject at the 50 and 200 µg doses, respectively. Peak body temperature > 38° was observed in 0%, 11%, 7%, and 34% at 25, 50, 100, and 200 µg, respectively. Mean acute adverse effect scores on the List of Complaints were 5.6, 9.2, 12, and 13 at 25, 50, 100, and 200 µg, respectively. Kidney and liver function parameters were unaltered. Six subjects reported transient flashback phenomena.ConclusionsThe single-dose administration of LSD is safe in regard to acute psychological and physical harm in healthy subjects in a controlled research setting.

Project description:BackgroundOur study aims to explore the effect of genetics on the pharmacodynamics (PD) and pharmacokinetics (PK) of cinacalcet in healthy Chinese subjects; to investigate the effect of dietary factors on cinacalcet, and to evaluate the safety of cinacalcet under fasting and non-fasting conditions using a bioequivalence trial.MethodsWe investigated the relationship of cinacalcet PK with single nucleotide polymorphisms (SNPs) of CYP3A4, CYP1A2 and CYP2D6, and of cinacalcet PD with SNPs of calcium-sensitive receptors (CASR) and vitamin D receptors (VDR) in 65 healthy Chinese subjects recruited to participate in this study. Our study was a phase I, open-label, randomized, two-period, two-sequence crossover, a single-center clinical study designed under both fasting and non-fasting conditions to investigate the effect of dietary factors on cinacalcet. Plasma cinacalcet concentrations were analyzed using a validated HPLC-MS/MS assay. Clinical laboratory tests evaluated safety. Thirteen SNPs of CASR, VDR, and CYP genes were selected for pharmacogenetic analysis.ResultsCYP3A4 rs4646437 was found to be associated with the PK of cinacalcet under fasting conditions (P<0.01). Subjects carrying T alleles of rs4646437 appeared to metabolize cinacalcet poorly. The Cmax and AUC of subjects in the non-fasting group were significantly higher (P<0.0001) than those in the fasting group. The Tmax, CL/F, and Vd/F in the fasting group were significantly higher (P<0.0001) than those in the non-fasting group. In the fasting group, the geometric least square mean ratios (T/R) of the Cmax and AUC0-t were 109.89% and 105.33%, and the corresponding 90% CIs were 98.36-122.79% and 98.04-113.15%, respectively. In the non-fasting group, the T/R of the Cmax and AUC0-t were 100.74% and 99.09%, and the corresponding 90% CIs were 92.65-109.54% and 94.79-103.58%, respectively. All adverse events (AEs) were mild, and no serious adverse events (SAEs) occurred during the bioequivalence trial.ConclusionsFollowing our investigation, we reached the following conclusions: CYP3A4 rs4646437 may affect cinacalcet PK; the reference and test preparations of cinacalcet were bioequivalent under fasting and non-fasting conditions and were safe to use; and dietary factors had a significant effect on the PK of cinacalcet, in that exposure to the drug increased when cinacalcet was taken after eating.

Dataset Information

Safety and efficacy of wiping lid margins with lid hygiene shampoo using the "eye brush", a novel lid hygiene item, in healthy subjects: a pilot study.

Publications

Safety and efficacy of wiping lid margins with lid hygiene shampoo using the "eye brush", a novel lid hygiene item, in healthy subjects: a pilot study.

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