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

Part of paid clinical trials in Berkeley, California.

Sponsor
University of California, Berkeley
Study ID
NCT07674966
Phase
PHASE1
Status
Completed

Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Atropine 0.01% Ophthalmic Solution — DRUG
    Two drops of 0.01% atropine sulfate solution
  • Atropine 0.02% Ophthalmic Solution — DRUG
    One drop of 0.02% atropine sulfate solution
  • Atropine 0.05% Ophthalmic Solution — DRUG
    Atropine 0.05% Ophthalmic Solution

Study Details

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.

Key Dates

Start date
Mar 16, 2022
Status verified
Mar 2026
Primary completion
Oct 9, 2022
Completion
Oct 9, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single drop of 0.02% atropine sulfate solution
    Participants received one drop of 0.02% atropine sulfate solution in one eye.
  • Experimental: Two drops of 0.01% atropine sulfate solution
    Participants received two drops of 0.01% atropine sulfate solution in one eye, spaced five minutes apart.
  • Other: observation of pupil responses
    Subjects will be observed until pupils fully recover from a single dose of one of the atropine concentrations used.

Primary Outcome Measure

Minimum pupil size [ Time Frame: 1-24 hours after drop application ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, BerkeleyBerkeleyCalifornia94720-2020-

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