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

NCT07178600 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-09-17

No results posted yet for this study

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.

Conditions

  • Adverse Drug Effect
  • Phenylephrine
  • Hypertension
  • Cardiovascular Complication
  • Ophthalmology
  • Ocular Discomfort

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

Sponsors & Collaborators

  • Instituto de Oftalmología Fundación Conde de Valenciana

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-02
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07178600 on ClinicalTrials.gov