Clinical trial Recruiting at 1 site Observational Ages 18 and up

Tropicamide/phenylephrine safety in hospitalized patients

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

Run by Instituto de Oftalmología Fundación Conde de Valenciana · NCT07178600 · Data updated 2026-11-12

This project will see if certain health factors make hospitalized adults more likely to have side effects after getting tropicamide/phenylephrine eye drops.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorInstituto de Oftalmología Fundación Conde de Valenciana
Academic / other
Locations1 site (Mexico City, Mexico Ciy)
StatusRecruiting
StartedSeptember 2, 2023
Main results expectedSeptember 2026
Study endsSeptember 2026
Registry record updatedSeptember 17, 2025
Trial IDNCT07178600 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Hospitalized adults (18+) at the Instituto de Oftalmología Conde de Valenciana scheduled for eye surgery who will receive two drops of tropicamide/phenylephrine 8 mg/50 mg/mL and consent to participate.

Probably not a fit

Patients with a known allergy to any component of the formulation or those who do not receive the medication are unlikely to gain benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This ambispective, longitudinal study will actively identify adverse reactions after topical ophthalmic administration of tropicamide/phenylephrine 8 mg/50 mg/mL in hospitalized patients. Researchers will collect baseline clinical data and vital signs, administer two drops, and then re-measure vitals and symptoms at 5, 15, and 30 minutes, and at 1 and 2 hours. Data will be gathered via a questionnaire and direct observation to link clinical determinants (comorbidities, medications, vital signs) with the occurrence and timing of adverse drug reactions. The study focuses on patients scheduled for ophthalmic procedures at the participating hospital and aims to inform safer administration practices.

Why it matters

Potential benefit: If successful, the study could identify patients at higher risk for side effects and support safer use of tropicamide/phenylephrine in hospitals.

How similar studies have gone: Previous topical-use studies generally report an acceptable risk–benefit profile for tropicamide and phenylephrine, but systemic cardiovascular safety at this concentration remains incompletely characterized.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients who have authorized participation in the study by signing informed consent.
* Patients over 18 years of age.
* Any sex.
* Patients from the "Instituto de Oftalmología Conde de Valenciana, IAP., sede Centro" who have been scheduled for a surgical procedure.
* Patients for whom the administration of two drops of tropicamide/phenylephrine 8 mg/50 mg/mL is indicated.
* Patients that presents any type of disease

Exclusion Criteria:

* Allergy to any component of the formulation.

Where it's running

  • Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro
    Mexico City, Mexico Ciy, Mexico
    Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.