Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02870478 |
| Other study ID # |
IND 128961 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
July 2016 |
| Est. completion date |
November 20, 2019 |
Study information
| Verified date |
November 2020 |
| Source |
University of California, Berkeley |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
