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

NCT07674966 | Completed Phase 1 FDA Drug

• 1 other identifier: 2021-09-14611
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does applying two drops of 0.01% atropine sulfate solution cause the same clinical effects as one drop of 0.02% atropine?
2. 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. 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.

Conditions

Myopia

Keywords

myopia; atropine

Outcome Measures

Primary Outcomes (1)

• Minimum pupil size

  Dynamic pupil responses to a single pulse of light were measured 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours after instilling the drop(s). The smallest pupil size (maximum pupil restriction) was used as the primary outcome measure.

  1-24 hours after drop application

Secondary Outcomes (1)

• Accommodative Amplitude

  1-24 hours after drop application

Study Arms (3)

Single drop of 0.02% atropine sulfate solution

EXPERIMENTAL

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

Drug: Atropine 0.02% Ophthalmic Solution

Two drops of 0.01% atropine sulfate solution

EXPERIMENTAL

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

Drug: Atropine 0.01% Ophthalmic Solution

observation of pupil responses

OTHER

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

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

Interventions

Atropine 0.01% Ophthalmic Solution DRUG

Two drops of 0.01% atropine sulfate solution

Two drops of 0.01% atropine sulfate solution; observation of pupil responses

Atropine 0.02% Ophthalmic Solution DRUG

One drop of 0.02% atropine sulfate solution

Single drop of 0.02% atropine sulfate solution; observation of pupil responses

Atropine 0.05% Ophthalmic Solution DRUG

Atropine 0.05% Ophthalmic Solution

observation of pupil responses

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720-2020, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Sarah E Singh, OD, PhD

  University of California, Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants could elect to participate in one or more of our study questions.

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: March 16, 2022
• Primary Completion: October 9, 2022
• Study Completion: October 9, 2022
• Last Updated: June 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: As this study is being registered retroactively (and the study is complete), all data can be made available upon request at this time (March 2026).
• Access Criteria: IPD can be accessed by emailing the PI who will make arrangements with appropriate UC Berkeley personnel to manage sharing.

Locations

US (1)