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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Instituto de Oftalmología Fundación Conde de Valenciana Academic / other |
| Locations | 1 site (Mexico City, Mexico Ciy) |
| Status | Recruiting |
| Started | September 2, 2023 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT07178600 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.
-
Using low-dose aspirin after preeclampsia to improve recovery
This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.
-
IMB-guided health education to boost medication taking and blood pressure control in adults with hypertension
This study tests a health-literacy program based on Information-Motivation-Behavioral Skills to help adults with hypertension who don’t take their medicines regularly to take them more consistently and better control their blood pressure.
-
Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF
This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.
-
Hypertension: Does Education Help Patients Manage Blood Pressure Better?
This study tests whether structured patient education improves blood pressure control and self-management in adults with hypertension who speak Turkish.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
Long-term GW906 treatment for people with essential hypertension
This trial tests whether long-term GW906 injections are safe and effective for adults with essential hypertension who completed an earlier GW906 study.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.