Clinical trial
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)
Name
EYN-MYD-TP-41PM
Description
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
Trial arms
Trial start
2023-11-28
Estimated PCD
2024-01-09
Trial end
2024-01-09
Status
Completed
Phase
Early phase I
Treatment
MydCombi
A single metered spray administered with the MydCombi dispenser
Arms:
Open Label Treatment
Other names:
tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%
Size
30
Primary endpoint
Mean Change in Pupil Diameter
30 minutes
Eligibility criteria
Inclusion Criteria:
* Ability to provide signed written consent prior to participation in any study-related procedures.
* Ability to return for the study treatment visit.
* Photopic screening pupil diameter ≤ 3.5 mm in each eye.
* Females not of childbearing potential or negative pregnancy test
Exclusion Criteria:
* Pregnant or Lactating
* Clinically significant abnormalities of the eye
* Active eye disease
* Using medication that can effect pupil dilation
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects receive the same intervention', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-04-18
1 organization
1 product
1 indication
Organization
EyenoviaProduct
MydCombiIndication
Mydriasis