Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
Condition: Mydriasis
MeSH terms: Mydriasis
Intervention: Tropicamide/Phenylephrine ophthalmic solution (TR/PE); Placebo
Intervention description: Tropicamide 1%/phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser; Eyewash administered with the Optejet microdose dispenser
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Ophthalmic Solutions; Tropicamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This trial was a double-masked, placebo-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. placebo. All participants in the trial were to receive each treatment.
Masking: Double (Participant, Outcomes Assessor)
Masking description: There were no differences in the presentation of study treatment administered and all study personnel conducting ophthalmic assessments after study treatment administration were masked to treatment assignment.
Enrollment: 76.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluated pupil dilation after administration of fixed combination
      tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits. At each visit,
      after baseline measurements, either the study drug or placebo was administered to both eyes,
      then pupil dilation and safety assessments were performed at specific time intervals.
    

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