Published Studies Related to Tropicamide (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. 
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%. 
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.
Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. [2006.11]
CONCLUSION: The 95% confidence interval of the difference in pupil size lay entirely within the range of equivalence. The single dose of 1% tropicamide and 10% phenylephrine was clinically equivalent to the three doses of the same drugs.
The mydriatic effect of multiple doses of tropicamide. [2005.11]
PURPOSE: We investigated whether two drops of 0.5% tropicamide produced a wider pupillary dilation when compared with a single drop and saline control in subjects with dark-colored irides... CONCLUSION: In young healthy subjects, compared with a single drop of tropicamide, two drops were associated with a greater degree of pupillary dilation on average over the 60-minute study period. However, the magnitude of the difference was small and not clinically significant. A single drop of tropicamide produced a pupillary diameter of at least 6 mm, which should be sufficient for the conduct of a thorough dilated fundus examination.
Clinical Trials Related to Tropicamide (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
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 MydriasertÂ® versus
reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic
insert MydriasertÂ® can control drug dispensation and decrease the number of nurse
interventions to obtain mydriasis in patients.
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.
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.
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)
Reports of Suspected Tropicamide (Tropicamide Ophthalmic) Side Effects
Skin Wrinkling (1),
Eye Irritation (1),
Anaphylactic Reaction (1),
Chest Pain (1),
Feeling Hot (1),
Eye Pruritus (1),
Renal Failure Acute (1),
Blood Pressure Increased (1), more >>