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

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)

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

MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye.

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