CompletedPhase 4

Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation

United States30 participantsStarted 2023-11-28

Plain-language summary

Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean Change in Pupil Diameter

Timeframe: 30 minutes

Trial details

NCT IDNCT06217796

SponsorEyenovia Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-09

Results submitted2024-03-22

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