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The Effects of Low Concentration Atropine on Pupil Size and Accommodation

Sponsor
University of California, Berkeley (Other)
Overall Status
Completed
CT.gov ID
NCT02870478
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
40.6
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether less frequent dosing of atropine drops may be as effective as daily dosing for the treatment of progressive myopia.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Myopia has become an epidemic in developed countries, particularly in Asian countries and in the United States. Myopia, or near-sightedness, is a result of uncontrolled axial elongation of the eye. Besides needing optical correction in order to see clearly, myopia can result in many sight-threatening complications, such as retinal thinning, retinal holes and tears, retinal detachment, and vascular proliferation. Atropine drops have been used in clinical practice for over 100 years at varying concentrations and different dosing regimens. The proposed small study seeks to establish evidence-based treatment (dosing) guidelines for the use of low dose atropine for myopia control.

The specific objectives of this study are:

  1. To assess the effects of 0.01% atropine on pupil dilation and accommodation as a measure of active drug levels in the eye when dosed twice per week compared to daily

  2. To assess the subjective effects of 0.01% atropine on the subjects' vision

The study will involve one 60-minute screening session, twenty 15-minute testing sessions, and one 8-hour testing session, for a total of 14 hours over five to six weeks. Following the screening exam (information will be collected on the screening form), the subject will be randomly assigned to treat their non-dominant eye with:

  1. 0.01% daily dosing for two weeks followed by a 1-week washout then 0.01% twice per week for two weeks

  2. 0.01% twice per week dosing for two weeks, followed by a 1-week washout, then 0.01% daily for two weeks.

Test sessions (expected to be no more than 15 mins in length) will be held daily during the testing period and scheduled at the subject's convenience. Session measurements will include best-corrected visual acuity, subjective amplitude of accommodation, objective amplitude of accommodation, and pupil size, as described previously (see screening section 7b). An anterior segment slit lamp biomicroscopy exam will also be performed to ensure good ocular health. The subject will also be asked to fill out a brief symptom questionnaire (attached) while they are present for the test session. Information will be recorded on the data collection sheet for this portion of the testing.

Additionally, measurements of pupil size and accommodation will be taken prior to the instillation of a single dose of 0.01% atropine, and then at 1min, 5 min, 30 min, 1hr, 2hr, 4hr, and 8hr post-instillation.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
A Study of Time and Dose-dependent Effect of Low Concentration Atropine on Accommodation and Pupil Size
Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Nov 20, 2019
Actual Study Completion Date :
Nov 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 0.01% atropine daily

Nightly dosing of 0.01% atropine

Drug: Atropine
Dosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy
Other Names:
  • atropine sulfate ophthalmic solution

    		•
    Experimental: 0.01% atropine twice per week

    Atropine dosed twice per week

    Drug: Atropine
    Dosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy
    Other Names:
  • atropine sulfate ophthalmic solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in pupil size at 1 week [Measured at baseline and again 1 week after first using drop]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Participants must have vision that is correctable to 20/20 in each eye

    • Participants must also have normal binocular vision (no history of manifest eye turns or eye surgeries to correct an eye turn)

    • Participants must have normal accommodation (amplitude and facility within a normal range based on the subject's age)

    • Participants must have normal ocular health

    Exclusion Criteria:

    • Previous chronic use of atropine

    • Participants who are pregnant, plan to become pregnant, or are breastfeeding

    • Sensitivity or allergy to atropine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UC Berkeley, Department of Vision Science Berkeley California United States 94720-2020

    Sponsors and Collaborators

    • University of California, Berkeley

    Investigators

    • Principal Investigator: Maria Liu, OD, MPH, PhD, UC Berkeley

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Berkeley
    ClinicalTrials.gov Identifier:
    NCT02870478
    Other Study ID Numbers:
    • IND 128961
    First Posted:
    Aug 17, 2016
    Last Update Posted:
    Nov 4, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Myopia
    Atropine
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Nov 4, 2020