Trial Outcomes & Findings for Side Effects of Atropine (SEA) Study (NCT NCT03593044)
NCT ID: NCT03593044
Last Updated: 2022-12-02
Results Overview
Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline (before) and one week after beginning treatment with drops
Results posted on
2022-12-02
Participant Flow
Subjects aged 22 to 26 years were enrolled in the study from July 2018 to January 2019.
Participant milestones
| Measure |
One Week Atropine
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Side Effects of Atropine (SEA) Study
Baseline characteristics by cohort
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23.9 years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
|
Spherical equivalent manifest refraction
|
-3.12 diopters
STANDARD_DEVIATION 2.87 • n=5 Participants
|
|
Eye color
Brown
|
12 Participants
n=5 Participants
|
|
Eye color
Blue
|
11 Participants
n=5 Participants
|
|
Eye color
Green
|
7 Participants
n=5 Participants
|
|
Eye color
Hazel
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (before) and one week after beginning treatment with dropsChange in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter
Outcome measures
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Photopic pupil size before administration of drops
|
4.9 millimeters
Standard Deviation 0.8
|
|
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Photopic pupil size after administration of drops for one week
|
5.1 millimeters
Standard Deviation 0.6
|
|
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Mesopic pupil size before administration of drops
|
5.9 millimeters
Standard Deviation 0.66
|
|
Diameter of the Pupil Measured With a Neuroptix Pupillometer
Mesopic pupil size after administration of drops for one week
|
5.9 millimeters
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: Baseline (before) and one week after beginning treatment with dropsInvestigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).
Outcome measures
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
High contrast distance visual acuity after administration of drops for one week
|
-0.1 logMAR
Standard Deviation 0.1
|
|
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
High contrast near visual acuity before drops
|
-0.2 logMAR
Standard Deviation 0.1
|
|
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
High contrast near visual acuity adter administration of drops for one week
|
-0.2 logMAR
Standard Deviation 0.1
|
|
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
High contrast distance visual acuity before drops
|
-0.1 logMAR
Standard Deviation 0.1
|
|
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
Low contrast visual acuity before drops
|
0.0 logMAR
Standard Deviation 0.1
|
|
Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts
Low contrast visual acuity after administration of drops for one week
|
0.0 logMAR
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: One week after beginning treatment with dropsInvestigators will measure the change in near point of accommodation (how close an object can be seen clearly) in centimeters and accommodative lag (error of focusing on near objects) in diopters.
Outcome measures
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Accommodative amplitude before drops
|
8.1 diopters
Standard Deviation 1.2
|
|
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Accommodative amplitude after administration of drops for one week
|
8.5 diopters
Standard Deviation 1.3
|
|
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Accommodative lag before drops
|
-0.8 diopters
Standard Deviation 1.7
|
|
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Accommodative lag after administration of drops for one week
|
-0.9 diopters
Standard Deviation 0.8
|
|
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Accommodative facility before drops
|
13.6 diopters
Standard Deviation 4
|
|
Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor
Accommodative facility after administration of drops for one week
|
14.0 diopters
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline (before) and one week after beginning treatment with dropsEach of the below scores are from an individual question that was answered before taking atropine drops and after taking atropine drops nightly for one week. Glare: 1 (good) to 10 (perfect); 10 is best Ghost images: 1 (good) to 10 (perfect); 10 is best Straing/tiredness: 1 (good) to 10 (perfect); 10 is best Changing vision: 1 (good) to 10 (perfect); 10 is best Headache frequency: 1 (very infrequent) to 10 (very frequent); 1 is best Distance clarity: 1 (good) to 10 (perfect): 10 is best Computer clarity: 1 (good) to 10 (perfect); 10 is best Small print clarity: 1 (good) to 10 (perfect); 10 is best Sports/hobbies vision: 1 (good) to 10 (perfect); 10 is best Overall vision: 1 (good) to 10 (perfect); 10 is best Light sensitivity: 1 (not sensitive at all) to 10 (very sensitive); 10 is best Discomfort during bright light: 1 (no discomfort) to 10 (extreme discomfort); 1 is best
Outcome measures
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Glare before drops
|
8.7 score on a question from 1 to 10
Standard Deviation 1.9
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Changing vision before drops
|
9.4 score on a question from 1 to 10
Standard Deviation 1.2
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Small print clarity before drops
|
9.5 score on a question from 1 to 10
Standard Deviation 1.1
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Overall vision after drops
|
9.1 score on a question from 1 to 10
Standard Deviation 0.9
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Light sensitivity after drops
|
3.1 score on a question from 1 to 10
Standard Deviation 2.5
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Discomfort during bright light before drops
|
2.7 score on a question from 1 to 10
Standard Deviation 1.9
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Discomfort during bright light after drops
|
2.0 score on a question from 1 to 10
Standard Deviation 1.7
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Glare after drops
|
9.0 score on a question from 1 to 10
Standard Deviation 1.3
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Ghost images before drops
|
9.8 score on a question from 1 to 10
Standard Deviation 0.9
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Ghost images after drops
|
9.7 score on a question from 1 to 10
Standard Deviation 0.7
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Strain/tiredness before drops
|
8.3 score on a question from 1 to 10
Standard Deviation 1.5
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
strain/tiredness after drops
|
8.7 score on a question from 1 to 10
Standard Deviation 1.6
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Changing vision after drops
|
9.4 score on a question from 1 to 10
Standard Deviation 0.9
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Headache frequency before drops
|
1.6 score on a question from 1 to 10
Standard Deviation 0.5
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Headache frequency after drops
|
1.7 score on a question from 1 to 10
Standard Deviation 0.5
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Distance clarity before drops
|
8.8 score on a question from 1 to 10
Standard Deviation 1.5
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Distance clarity after drops
|
8.7 score on a question from 1 to 10
Standard Deviation 1.2
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Computer clarity before drops
|
9.5 score on a question from 1 to 10
Standard Deviation 0.8
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Computer clarity after drops
|
9.3 score on a question from 1 to 10
Standard Deviation 1.0
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Small print clarity after drops
|
9.1 score on a question from 1 to 10
Standard Deviation 1.0
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Vision during sports/hobbies before drops
|
9.6 score on a question from 1 to 10
Standard Deviation 0.6
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Vision during sports/hobbies after drops
|
9.6 score on a question from 1 to 10
Standard Deviation 0.6
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Overall vision before drops
|
9.4 score on a question from 1 to 10
Standard Deviation 1.0
|
|
Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.
Light sensitivity before drops
|
2.8 score on a question from 1 to 10
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline (before) and one week after beginning treatment with dropsWe will measure the change in eye pressure between baseline visit and follow up visit (after one week on treatment) measured with Tonopen and recorded in mmHg.
Outcome measures
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
Change in Intraocular Pressure Using a Tonopen
Intraocular pressure of left eyes before drops
|
15.7 millimeters Mercury
Standard Deviation 2.8
|
|
Change in Intraocular Pressure Using a Tonopen
Intraocular pressure of right eyes before drops
|
15.5 millimeters Mercury
Standard Deviation 2.9
|
|
Change in Intraocular Pressure Using a Tonopen
Intraocular pressure of right eyes after administration of drops for one week
|
17.0 millimeters Mercury
Standard Deviation 2.8
|
|
Change in Intraocular Pressure Using a Tonopen
Intraocular pressure of left eyes after administration of drops for one week
|
16.4 millimeters Mercury
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline (before) and one week after beginning treatment with dropsInvestigators will measure accommodative facility (ability to change focus from far to near) in number of cycles between baseline visit and follow up visit (after one week on treatment).
Outcome measures
| Measure |
One Week Atropine
n=31 Participants
0.01% concentration atropine drops
0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
|
|---|---|
|
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.
Accommodative facility before drops
|
13.6 cycles per minute
Standard Deviation 4
|
|
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.
Accommodative facility after administering drops for one week
|
14.0 cycles per minute
Standard Deviation 3.8
|
Adverse Events
One Week Atropine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeffrey Walline
The Ohio State University College of Optometry
Phone: (614) 247-6840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place