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NOT YET RECRUITING
NCT07075224
PHASE1/PHASE2

Pharmacodynamics of a Fixed Dose Combination of 0.34% Tropicamide and 2.5% Phenylephrine Hydrochloride, Eye Drop, Solution

Sponsor: Unither Pharmaceuticals, France

View on ClinicalTrials.gov

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®

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-07-15

Completion Date

2025-09-30

Last Updated

2025-07-20

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

IMP 08P2002F0

Fixed combination of 0.34 % tropicamide and 2.5 % phenylephrine Hydrochloride (HCl) Eye drop Solution.

DRUG

Mydriasert® insert

0.28 mg tropicamide and 5.4 mg phenylephrine hydrochloride

Locations (2)

Ophthalmiatreion Athinon

Athens, Greece

Iaso Thessalia General Clinic Private Obstetrics S.A.

Larissa, Greece