Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation (MIST-1)
Mydriasis
About this trial
This is an interventional diagnostic trial for Mydriasis
Eligibility Criteria
Inclusion Criteria:
- Ability to provide written consent and return for all study visits
- Photopic pupil diameter <= 3.5 mm in each eye
Exclusion Criteria:
- Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride
- History of benign prostatic hyperplasia
- Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug
- History of closed-angle glaucoma
- Anatomically narrow anterior chamber angles
- Ocular surgery or laser treatment of any kind
- History of chronic or acute uveitis
- History of traumatic iritis or hyphema
- History of traumatic mydriasis or angle recession
- History of heterochromia
- Irregularly-shaped pupil secondary to ocular trauma or congenital defect.
- History of neurogenic pupil disorder
- History of anterior chamber intraocular lens (IOL) or iris-fixated IOL
- History of iris surgery, iris atrophy, or iris-cornea apposition/touch
- Unwilling or unable to discontinue use of contact lenses at treatment visits.
- Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears.
- Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment and/or follow-up
- Pregnancy or lactation
Sites / Locations
- WCCT
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Other
Other
Other
Other
Other
Other
1-TR/PE, 2-TR, 3-PE
1-TR/PE, 2-PE, 3-TR
1-TR, 2-TR/PE, 3-PE
1-TR, 2-PE, 3-TR/PE
1-PE, 2-TR/PE, 3-TR
1-PE, 2-TR, 3-TR/PE
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.