NCT07075224

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Unither Pharmaceuticals, France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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®

Conditions

• Mydriasis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-15
• Primary completion: 2025-09-27
• Completion: 2025-09-30
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

2 sites across 1 country: Greece