Trial · NCT03334253
Low-Dose Atropine for Treatment of Myopia
NCT03334253, Phase 3, Completed, Jaeb Center for Health Research; results first posted 2023-05-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low-Dose Atropine for Treatment of Myopia. Trials, record NCT03334253. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03334253
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low-Dose Atropine for Treatment of Myopia
- NCT number
- NCT03334253
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Myopia
- Interventions
- Atropine, Placebo Eyedrops
- First posted
- 2017-11-07
- Last updated
- 2026-07-31
- Results first posted
- 2023-05-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | At 24 months | The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. |
| Primary | Primary Outcome Measure Stratified by Sex | at 24 months | NIH-required analysis. Primary outcome measure (stratified by sex): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. |
| Primary | Primary Outcome Measure Stratified by Race | by 24 months | NIH-required analysis. Primary outcome measure (stratified by race): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. |
| Primary | Primary Outcome Measure Stratified by Ethnicity | at 24 months | NIH-required analysis. Primary outcome measure (stratified by ethnicity): The primary analysis will be a treatment group comparison of change from baseline to 24-months in spherical equivalent refractive error (SER), as measured by a masked examiner using cycloplegic autorefraction (on-treatment comparison). The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. The treatment group difference (atropine - placebo) and a 95% confidence interval will be calculated based on the model estimates at 24 months. |
| Primary | Primary Outcome: Mean Change in Spherical Equivalent Refractive Error at 24 Months | 24 months | The mean of the three readings from autorefraction in each eye will be calculated and then the mean of both eyes for each participant will be used for the analysis. |
| Secondary | Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent | At 30 months | Treatment group comparison of change from baseline to 30 months in spherical equivalent in each eye as measured by a masked examiner using cycloplegic autorefraction (off-treatment comparison). Calculated based on the model estimates at 24 months. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | At 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent | At 30 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Atropine Group | <=-3.50 Diopters | 0 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Placebo Group | <=-3.50 Diopters | 0 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Atropine Group | >-3.50 to -3.00 Diopters | 1 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Placebo Group | >-3.50 to -3.00 Diopters | 0 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Atropine Group | >-3.00 to -2.50 Diopters | 1 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Placebo Group | >-3.00 to -2.50 Diopters | 0 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Atropine Group | >-2.50 to -2.00 Diopters | 5 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Placebo Group | >-2.50 to -2.00 Diopters | 2 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Atropine Group | >-2.00 to -1.50 Diopters | 8 | Participants | |
| Treatment Group Comparison of Change in Spherical Equivalent Refractive Error. | Placebo Group | >-2.00 to -1.50 Diopters | 7 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atropine Group | 125 | |
| Overall Study | STARTED | Placebo Group | 62 | |
| Overall Study | COMPLETED | Atropine Group | 118 | |
| Overall Study | COMPLETED | Placebo Group | 57 | |
| Overall Study | NOT COMPLETED | Atropine Group | 7 | |
| Overall Study | NOT COMPLETED | Placebo Group | 5 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye Irritiation | Eye disorders | Atropine Group | 90 | 125 | |
| other | Eye Irritiation | Eye disorders | Placebo Group | 51 | 62 | |
| other | Photophobia | Eye disorders | Atropine Group | 32 | 125 | |
| other | Photophobia | Eye disorders | Placebo Group | 17 | 62 | |
| other | Vision Blurred | Eye disorders | Atropine Group | 17 | 125 | |
| other | Vision Blurred | Eye disorders | Placebo Group | 10 | 62 | |
| other | Allergic Conjunctivitis | Eye disorders | Atropine Group | 10 | 125 | |
| other | Allergic Conjunctivitis | Eye disorders | Placebo Group | 5 | 62 | |
| other | Ocular Discomfort | Eye disorders | Atropine Group | 8 | 125 | |
| other | Ocular Discomfort | Eye disorders | Placebo Group | 5 | 62 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atropine Group | 0 | 125 |
| Total, all-cause mortality | Placebo Group | 0 | 62 |
| Total, other adverse events | Atropine Group | 109 | 125 |
| Total, other adverse events | Placebo Group | 56 | 62 |
| Total, serious adverse events | Atropine Group | 2 | 125 |
| Total, serious adverse events | Placebo Group | 0 | 62 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY011751 | Pediatric Eye Disease Investigator Group Coordinating Center | KRAKER, RAYMOND | JAEB CENTER FOR HEALTH RESEARCH, INC. | NATIONAL EYE INSTITUTE | 1997 to 2018 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Atropine Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Atropine Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03334253
GET https://conductscience.org/api/trials/v1/NCT03334253/results?page=2