Phase 2
N=31
Side Effects of Atropine (SEA) Study
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03593044 ↗Enrolled (actual)
31
Serious AEs
—
Results posted
Dec 2022
Primary outcome: Primary: Diameter of the Pupil Measured With a Neuroptix Pupillometer — 4.9; 5.1; 5.9; 5.9 millimeters — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 0.01% concentration atropine drops (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Jeffrey J. Walline, OD PhD
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diameter of the Pupil Measured With a Neuroptix Pupillometer |
4.9; 5.1; 5.9; 5.9 | 0.002 sig |
| PRIMARY Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts |
-0.1; -0.1; -0.2; -0.2; 0.0; 0.0 | 0.96 |
| SECONDARY Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor |
8.1; 8.5; -0.8; -0.9; 13.6; 14.0 | 0.10 |
| SECONDARY Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops. |
8.7; 9.0; 9.8; 9.7; 8.3; 8.7 | 0.3 |
| SECONDARY Change in Intraocular Pressure Using a Tonopen |
15.5; 17.0; 15.7; 16.4 | 0.001 sig |
| SECONDARY Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute. |
13.6; 14.0 | — |
Summary
This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.
Eligibility Criteria
Inclusion Criteria
-N/A
Exclusion Criteria
- Outside of age range
- History of accommodative (focusing) issues or therapy
Data sourced from ClinicalTrials.gov (NCT03593044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.