At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pharmacodynamics of Investigational Medicinal Product (IMP) 08P2002F0 (Fixed Dose Combination of 0.34 % Tropicamide and 2.5 % Phenylephrine Hydrochloride, Eye Drop Solution), a New Ophthalmic Mydriatic Solution in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating IMP 08P2002F0 and Mydriasert® insert for Mydriasis. Completed, enrolled 20 participants across 2 sites.
Detailed Summary
The objective of this study is to explore pharmacodynamic effects and safety of IMP 08P2002F0 for dilation of the pupil, a solution combining two mydriatic agents tropicamide and phenylephrine hydrochloride at the concentrations of 0.34% and 2.5% respectively, versus Mydriasert®
Study Details
Timeline
Arms & Interventions
First Intervention (6 hours of follow-up):1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation.
First Intervention (6 hours of follow-up):1 insert will be kept onto the eye for one hour. Then Insert is retrieved and rinsing will be performed with NaCl after retrieval of insert (performed after a contact time of 60 min). Then, a Washout (2-7 days), and a Second Intervention (6 hours of follow-up) : 1 eye drop. Rinsing will be performed with NaCl 30 min after instillation.
Interventions
Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution.
0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride