An Investigation of Topical Ophthalmic Low-Dose Atropine on Pupil Size and Accommodation

Inclusion criteria

• Subjects may be male or female, of any race, and between 18-40 years old at the time of screening.
• Patients must have best spectacle corrected visual acuity of at least 0.10 logMAR (20/25) in each eye.
• Subjects must be willing and able to apply eye drops to their non-dominant eye and to return for all scheduled follow-up visits.

Exclusion criteria

• Subjects with any contraindication to atropine use (as listed on package insert). At the time of this submission, the only contraindication listed is: "Hypersensitivity or allergic reaction to any ingredient in formulation"
• Subjects using monamine oxidase inhibitors (MAOIs). These are: Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), and Tranylcypromine (Parnate).
• Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
• Subjects with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization >1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring). This includes any patient with open-angle glaucoma, regardless of medication regimen or control. Additionally, any patient with an intra-ocular pressure (IOP) greater than 21 mm Hg at baseline is specifically excluded from eligibility. Subjects with narrow angles (less than Van Herick angle of 3) will also be excluded.
• Subjects who are pregnant, planning to become pregnant or breastfeeding during the course of the study.