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Tropicacyl (Tropicamide Ophthalmic) - Summary

 
 



TROPICACYL SUMMARY

TROPICACYL® Tropicamide Ophthalmic Solution, USP is an anticholinergic prepared as a sterile topical ophthalmic solution in two strengths.

TROPICACYL (Tropicamide OPHTHALMIC) is indicated for the following:

For mydriasis and cycloplegia for diagnostic procedures.


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NEWS HIGHLIGHTS

Published Studies Related to Tropicacyl (Tropicamide Ophthalmic)

A double-blind, placebo-controlled, randomized, crossover pilot study of the safety and efficacy of multiple doses of intra-oral tropicamide films for the short-term relief of sialorrhea symptoms in Parkinson's disease patients. [2011]
OBJECTIVE: This proof-of-concept, pilot study aimed to explore the safety and anti-sialorrhea efficacy of single doses of intra-oral slow dissolving thin films containing tropicamide (NH004) or placebo. METHODS: Nineteen non-demented, idiopathic stable or fluctuating PD patients who complained of sialorrhea received 3 doses (0.3, 1, 3mg) of tropicamide and placebo in random order, separated by 7 days...

Effective pupil dilatation with a mixture of 0.75% tropicamide and 2.5% phenylephrine: A randomized controlled trial. [2009.09]
CONCLUSIONS: The mixture of 0.75% tropicamide and 2.5% phenylephrine is superior to our standard application of 1% tropicamide alternating with 10% phenylephrine. It provides faster and more successful pupil dilatation within 40 min.

Mydriatic and cardiovascular effects of phenylephrine 2.5% versus phenylephrine 10%, both associated with tropicamide 1%. [2009]
BACKGROUND/AIMS: To evaluate and compare cardiovascular effects (blood pressure and heart rate) of phenylephrine 2.5% versus phenylephrine 10%, and compare pupil diameter before and after instillation of eyedrops... CONCLUSION: Our results corroborate the finding that one single drop of either 2.5 or 10% phenylephrine is safe and, when 1% tropicamide is combined, satisfactory pupil dilation is achieved. Copyright 2009 S. Karger AG, Basel.

Comparison of the effectiveness of mydriasis by two instillation methods of combined 0.75% tropicamide and 2.5% phenylephrine eye drop in preterm infants. [2012]
CONCLUSION: Both instillation methods produced consistently sufficient mydriasis

A double-blind, placebo-controlled, randomized, crossover pilot study of the safety and efficacy of multiple doses of intra-oral tropicamide films for the short-term relief of sialorrhea symptoms in Parkinson's disease patients. [2011.11.15]
OBJECTIVE: This proof-of-concept, pilot study aimed to explore the safety and anti-sialorrhea efficacy of single doses of intra-oral slow dissolving thin films containing tropicamide (NH004) or placebo. METHODS: Nineteen non-demented, idiopathic stable or fluctuating PD patients who complained of sialorrhea received 3 doses (0.3, 1, 3mg) of tropicamide and placebo in random order, separated by 7 days...

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Clinical Trials Related to Tropicacyl (Tropicamide Ophthalmic)

Study of the Safety and Efficacy of Tropicamide Thin Films to Reduce Hypersalivation in Parkinson's Patients [Active, not recruiting]
To study the safety and efficacy of tropicamide 1 mg intra-oral slow dissolving muco-adhesive thin films compared to placebo to reduce hypersalivation in PD patients manifesting sialorrhea complaints.

Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation [Completed]
The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.

CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment [Terminated]
Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.

A New More Efficient Cycloplegia Scheme [Recruiting]
The purpose of this study is to determine whether tropicamide + phenylephrine cyclopentolate + applied for once waiting 30 minutes to retinoscopy (new scheme) is not inferior to apply cyclopentolate alone and wait 45 minutes to retinoscopy (traditional scheme)

Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Fabry Patients [Active, not recruiting]
This study aims to evaluate blood oxygenation at the optic nerve head in relation with visual field losses observed in many Fabry patients. Data collected will allow to evaluate if there is a link between these two entities. Study will last up to 2 years during which a limited number of Fabry patients will be compared to a control group to confirm any relationship between blood flow and field losses, and to see if these results vary over time. HYPOTHESIS 1. Fabry patients will present significant differences in visual fields compared to control 2 There will be variability of the visual field defects on the long term but not on the short term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic nerve head will be the same for both groups.

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Page last updated: 2013-02-10

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