Tropicamide/phenylephrine safety in hospitalized patients
Characterization and Association of Clinical Determinants With the Occurrence of Adverse Drug Reactions Following the Administration of Tropicamide/Phenylephrine in Hospitalized Patients.
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 type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana Academic / other |
| Locations | 1 site (Mexico City, Mexico Ciy) |
| Trial ID | NCT07178600 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mexico City, Mexico Ciy
- Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro — Mexico City, Mexico Ciy, Mexico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.