Dataset Information

Aqueous column changes in the episcleral veins after the instillation of ripasudil versus latanoprost: a randomized, double-blind, crossover clinical trial.

ABSTRACT: To investigate whether the topical administration of ripasudil ophthalmic solution enhances aqueous outflow in the episcleral vein of the human eye. Two-sequence, prospective, randomized, double-blind, crossover trial. Sixteen eyes of 16 healthy participants were recruited in this study. Participants were randomized into one of the two crossover sequences to the instillation of ripasudil or the control drug, latanoprost, followed by a washout period of more than 2 days, and crossed over to the alternative instillation. The aqueous columns in the episcleral veins were recorded using a video capture system connected to a slit-light microscope (hemoglobin video imaging) before and 2 and 8 h after the instillation. Comparisons between ripasudil and latanoprost for the changes of the aqueous column width after the instillation. Two hours after the instillation, the ripasudil group had significantly greater dilation of the aqueous column width than the latanoprost group. Eight hours after the instillation, the ripasudil group had significantly greater dilation of the aqueous column width than the latanoprost group. Hemoglobin video imaging revealed that the topical administration of ripasudil ophthalmic solution enhanced aqueous outflow in the episcleral vein of the human eye.

SUBMITTER: Suzuki M

PROVIDER: S-EPMC9464201 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Aqueous column changes in the episcleral veins after the instillation of ripasudil versus latanoprost: a randomized, double-blind, crossover clinical trial.

Suzuki Marie M Suzuki Yohei Y Komori Ryohei R Orii Yusuke Y Arimura Shogo S Iwasaki Kentaro K Takamura Yoshihiro Y Inatani Masaru M

Scientific reports 20220910 1

To investigate whether the topical administration of ripasudil ophthalmic solution enhances aqueous outflow in the episcleral vein of the human eye. Two-sequence, prospective, randomized, double-blind, crossover trial. Sixteen eyes of 16 healthy participants were recruited in this study. Participants were randomized into one of the two crossover sequences to the instillation of ripasudil or the control drug, latanoprost, followed by a washout period of more than 2 days, and crossed over to the a ...[more]

PMID: 36088479

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Project description:IntroductionMultidrug regimens for glaucoma treatment often result in adherence issues due to inconvenience; these issues may be improved with fixed-dose combination drugs. The ophthalmic solution of ripasudil-brimonidine fixed-dose combination (RBFC; K-232) is the first treatment combining a Rho kinase inhibitor and an α2-adrenoceptor agonist, and has demonstrated ability to lower intraocular pressure (IOP) and have various effects on conjunctival hyperemia and corneal endothelial cell morphology. This study evaluates the pharmacologic effects of RBFC treatment versus its separate components-ripasudil or brimonidine.MethodsThis single-center, prospective, randomized, open-label, blinded endpoint study with 3 × 3 crossover design randomly assigned healthy adult men to three groups (1:1:1) to undergo consecutive 8-day administration phases (with drug-free intervals of at least 5 days). Subjects received twice-daily instillation of RBFC → ripasudil → brimonidine (group A), ripasudil → brimonidine → RBFC (group B), or brimonidine → RBFC → ripasudil (group C). Endpoints included change in IOP, severity of conjunctival hyperemia, corneal endothelial cell morphology, pupil diameter, and pharmacokinetics.ResultsEighteen subjects were assigned in total (six to each group). RBFC significantly reduced IOP from baseline at 1 h post-instillation on days 1 and 8 (12.7 vs. 9.1 and 9.0 mmHg, respectively; both P < 0.001), and provided significantly greater IOP reductions than ripasudil or brimonidine at several time points. The most common adverse drug reaction with all three treatments was mild conjunctival hyperemia, which transiently increased in severity with RBFC or ripasudil, peaking at 15 min post-instillation. In post hoc analyses, conjunctival hyperemia scores were lower with RBFC than with ripasudil at several time points. Transient morphologic changes in corneal endothelial cells occurred for up to several hours with RBFC or ripasudil, but not with brimonidine. Pupil diameter did not change with RBFC.ConclusionRBFC significantly reduced IOP compared with each agent alone. A combination of each agent's pharmacologic profile was observed in that of RBFC.Trial registrationJapan Registry of Clinical Trials; Registration No. jRCT2080225220.

Project description:BackgroundAspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.MethodsThis was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.ResultsAspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.ConclusionUsing a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of aspartame does not have any detectable psychological or metabolic effects in humans.Trial registrationISRCTN Registry ISRCTN39650237.

Dataset Information

Aqueous column changes in the episcleral veins after the instillation of ripasudil versus latanoprost: a randomized, double-blind, crossover clinical trial.

Publications

Aqueous column changes in the episcleral veins after the instillation of ripasudil versus latanoprost: a randomized, double-blind, crossover clinical trial.

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