Mydriasis with micro-array print touch-free tropicamide-phenylephrine fixed combination MIST: pooled randomized...

Area of Science:

• Ophthalmology
• Clinical Pharmacology

Background:

• Mydriasis is essential for various ophthalmic examinations.
• Evaluating the efficacy and safety of mydriatic agents is crucial for optimizing clinical practice.

Purpose of the Study:

• To compare the pupil dilating effects of a fixed-combination tropicamide-phenylephrine (TR-PH) with its individual components and placebo.
• To assess the safety and tolerability of TR-PH in a clinical setting.

Main Methods:

• Prospective, double-masked, controlled, cross-over superiority trials involving microdosed mydriatics.
• Two pooled Phase III trials (MIST-1 and MIST-2) administered TR-PH, phenylephrine 2.5% (PH), tropicamide 1% (TR), or placebo.
• Pupil diameter was measured using digital pupillometry at 35 minutes post-administration.

Main Results:

• Pooled analysis included 131 subjects.
• TR-PH showed significantly greater pupil dilation compared to TR (0.58 mm difference, p < 0.0001), PH (3.87 mm difference, p < 0.0001), and placebo (4.65 mm difference, p < 0.0001).
• Adverse events were infrequent, transient, and mild.

Conclusions:

• TR-PH demonstrated superior mydriatic efficacy compared to tropicamide, phenylephrine, and placebo.
• The fixed combination of TR-PH was safe and well-tolerated in the study population.