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

University of California (UC), Berkeley

Status and phase: Completed; Phase 1

Conditions: Myopia

Treatments: Drug: Atropine 0.01% Ophthalmic Solution; Drug: Atropine 0.05% Ophthalmic Solution; Drug: Atropine 0.02% Ophthalmic Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07674966

2021-09-14611

Details and patient eligibility

About

The goal of this clinical study is to learn about the short-term physiological effects of low-dose atropine in healthy volunteers. The study seeks to examine three questions related to low-dose topically applied ophthalmic atropine:

1. Does applying two drops of 0.01% atropine sulfate solution cause the same clinical effects as one drop of 0.02% atropine?
2. How quickly do the pupil responses and accommodative amplitudes recover following a dose of 0.01% atropine, 0.02% atropine, and 0.05% atropine?
3. Does applying a single drop of 0.02% atropine sulfate solution cause the same clinical effects in participants with light vs. dark iris colors? Participants will have their pupil size and accommodative status measured at appropriate intervals to answer the questions above.

Enrollment: 24 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects may be male or female, of any race, and between 18-40 years old at the time of screening.
2. Patients must have best spectacle corrected visual acuity of at least 0.10 logMAR (20/25) in each eye.
3. 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

1. 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"
2. Subjects using monamine oxidase inhibitors (MAOIs). These are: Isocarboxazid (Marplan), Phenelzine (Nardil), Selegiline (Emsam), and Tranylcypromine (Parnate).
3. 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.
4. 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.
5. Subjects who are pregnant, planning to become pregnant or breastfeeding during the course of the study.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

24 participants in 3 patient groups

Single drop of 0.02% atropine sulfate solution

Experimental group

Description:

Participants received one drop of 0.02% atropine sulfate solution in one eye.

Treatment:

Drug: Atropine 0.02% Ophthalmic Solution

Two drops of 0.01% atropine sulfate solution

Experimental group

Description:

Participants received two drops of 0.01% atropine sulfate solution in one eye, spaced five minutes apart.

Treatment:

Drug: Atropine 0.01% Ophthalmic Solution

observation of pupil responses

Other group

Description:

Subjects will be observed until pupils fully recover from a single dose of one of the atropine concentrations used.

Treatment:

Drug: Atropine 0.02% Ophthalmic Solution

Drug: Atropine 0.05% Ophthalmic Solution

Drug: Atropine 0.01% Ophthalmic Solution