Clinical Trial

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

Study acronym: SOLMYD-PD
Completed Phase 1/2
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®
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-10.
Status change: Not Yet Recruiting → Completed 2026-05-20
Trial Details
NCT Number NCT07075224
Lead Sponsor Unither Pharmaceuticals, France
Conditions Mydriasis
Enrollment 20 participants
Start Date 2025-11-01
Primary Completion 2025-11-09 (estimated)
Study Completion 2025-11-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-17