A Single-Center, Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution (Mydcombi®) Administered With the Mydcombi Dispenser for Pupil Dilation (THE MIST-2.1 STUDY)
MydCombi
Eye Diseases
+ Pupil Disorders
+ Mydriasis
Diagnostic Study
Summary
Study start date: November 28, 2023
Actual date on which the first participant was enrolled.This study focuses on testing a medicine called MydCombi, which is used to make the pupils of the eyes larger, a process known as mydriasis. This is important for eye exams and other diagnostic procedures where doctors need a better view inside the eye. The study is particularly interested in finding out if using half the usual dose of MydCombi, which is just one spray per eye instead of two, is still effective for pupil dilation. This research might help improve patient comfort and reduce medication use during eye examinations. Participants in the study will receive a single spray of MydCombi directly onto the cornea of each eye. The goal is to observe how well the pupils dilate with this reduced dosage. Although no specific outcomes are listed, the study will likely monitor the degree and duration of pupil dilation and any side effects that may occur. This approach aims to establish whether a lower dose can still achieve the desired dilation safely and effectively.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location