drugset
drugset / Trial / NCT07075224

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

NCT07075224 ↗

Phase 1/2 Completed 20 enrolled Unither Pharmaceuticals, France
RandomizedCrossoverSingle-blindDiagnostic

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®

Timeline

Start
2025-11-01
Primary completion
2025-11-09
Completion
2025-11-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Phenylephrine Small molecule 2.5 % Other
Subject Phenylephrine Small molecule 5.4 mg Other
Subject tropicamide Small molecule 0.28 mg Other
Subject tropicamide Small molecule 0.34 % Other

Indications

No indication recorded.