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RECRUITING
NCT07178600

Clinical Determinants and Adverse Reactions to Tropicamide/Phenylephrine in Hospitalized Patients.

Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

View on ClinicalTrials.gov

Summary

To evaluate the association between clinical determinants and the occurrence of adverse drug reactions in hospitalized patients who received tropicamide/phenylephrine 8 mg/50 mg/mL. An ambispective, interventional, longitudinal study will be conducted to actively identify adverse reactions to tropicamide/phenylephrine 8 mg/50 mg/mL, as well as the clinical determinants that may predispose patients to the occurrence of an adverse drug reaction (ADR). Data will be collected through the administration of a questionnaire and measurement of vital signs prior to the administration of tropicamide/phenylephrine 8 mg/50 mg/mL, and subsequently at 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours after administration, with the aim of establishing an association between these variables.

Official title: Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2023-09-02

Completion Date

2026-09

Last Updated

2025-09-17

Healthy Volunteers

No

Interventions

DRUG

Ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL.

Measurement of vital signs after ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL

Locations (1)

Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro

Mexico City, Mexico Ciy, Mexico