Trial Outcomes & Findings for Low-Dose Atropine for Treatment of Myopia (NCT NCT03334253)
NCT ID: NCT03334253
Last Updated: 2026-07-31
Results Overview
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.
COMPLETED
PHASE3
200 participants
At 24 months
2026-07-31
Participant Flow
Two hundred patients were enrolled into the run-in phase; 13 were ineligible for randomization
Participant milestones
| Measure |
Atropine Group
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
62
|
|
Overall Study
COMPLETED
|
118
|
57
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Atropine Group
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
|
Overall Study
Moved residence
|
2
|
2
|
Baseline Characteristics
Flat corneal radius was not available for 1 patient in the placebo group.
Baseline characteristics by cohort
| Measure |
Placebo Group
n=62 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
Total
n=187 Participants
Total of all reporting groups
|
Atropine Group
n=125 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
|---|---|---|---|
|
Age, Continuous
|
10.1 years
STANDARD_DEVIATION 1.8 • n=62 Participants
|
10.1 years
STANDARD_DEVIATION 1.8 • n=187 Participants
|
10.1 years
STANDARD_DEVIATION 1.8 • n=125 Participants
|
|
Age, Customized
5 to <7 years
|
3 Participants
n=62 Participants
|
9 Participants
n=187 Participants
|
6 Participants
n=125 Participants
|
|
Age, Customized
7 to <9 years
|
13 Participants
n=62 Participants
|
41 Participants
n=187 Participants
|
28 Participants
n=125 Participants
|
|
Age, Customized
9 to <11 years
|
20 Participants
n=62 Participants
|
70 Participants
n=187 Participants
|
50 Participants
n=125 Participants
|
|
Age, Customized
11 to <13 years
|
26 Participants
n=62 Participants
|
67 Participants
n=187 Participants
|
41 Participants
n=125 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=62 Participants
|
101 Participants
n=187 Participants
|
65 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=62 Participants
|
86 Participants
n=187 Participants
|
60 Participants
n=125 Participants
|
|
Race/Ethnicity, Customized
White (not Hispanic or Latino)
|
28 Participants
n=62 Participants
|
86 Participants
n=187 Participants
|
58 Participants
n=125 Participants
|
|
Race/Ethnicity, Customized
White Hispanic or Latino
|
9 Participants
n=62 Participants
|
30 Participants
n=187 Participants
|
21 Participants
n=125 Participants
|
|
Race/Ethnicity, Customized
Black
|
14 Participants
n=62 Participants
|
34 Participants
n=187 Participants
|
20 Participants
n=125 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
4 Participants
n=62 Participants
|
20 Participants
n=187 Participants
|
16 Participants
n=125 Participants
|
|
Race/Ethnicity, Customized
West Asian / South Asian
|
2 Participants
n=62 Participants
|
6 Participants
n=187 Participants
|
4 Participants
n=125 Participants
|
|
Race/Ethnicity, Customized
More Than one race
|
5 Participants
n=62 Participants
|
11 Participants
n=187 Participants
|
6 Participants
n=125 Participants
|
|
Eye Color
Brown
|
41 Participants
n=62 Participants
|
123 Participants
n=187 Participants
|
82 Participants
n=125 Participants
|
|
Eye Color
Not Brown
|
21 Participants
n=62 Participants
|
64 Participants
n=187 Participants
|
43 Participants
n=125 Participants
|
|
Number of Biological Parents with Myopia
0
|
11 Participants
n=62 Participants
|
27 Participants
n=187 Participants
|
16 Participants
n=125 Participants
|
|
Number of Biological Parents with Myopia
1
|
24 Participants
n=62 Participants
|
75 Participants
n=187 Participants
|
51 Participants
n=125 Participants
|
|
Number of Biological Parents with Myopia
2
|
20 Participants
n=62 Participants
|
72 Participants
n=187 Participants
|
52 Participants
n=125 Participants
|
|
Number of Biological Parents with Myopia
Myopia history unknown for one or both parents
|
7 Participants
n=62 Participants
|
13 Participants
n=187 Participants
|
6 Participants
n=125 Participants
|
|
Current Refractive Correction (Single-vision Spectacles or Contact Lenses)
Yes
|
61 Participants
n=62 Participants
|
186 Participants
n=187 Participants
|
125 Participants
n=125 Participants
|
|
Current Refractive Correction (Single-vision Spectacles or Contact Lenses)
No
|
1 Participants
n=62 Participants
|
1 Participants
n=187 Participants
|
0 Participants
n=125 Participants
|
|
Distance Visual Acuity in Habitual Refractive Correction (Mean of Both Eyes)
<-0.2 logMAR
|
1 Participants
n=62 Participants
|
1 Participants
n=187 Participants
|
0 Participants
n=125 Participants
|
|
Distance Visual Acuity in Habitual Refractive Correction (Mean of Both Eyes)
-0.2 to < -0.1 logMAR
|
5 Participants
n=62 Participants
|
23 Participants
n=187 Participants
|
18 Participants
n=125 Participants
|
|
Distance Visual Acuity in Habitual Refractive Correction (Mean of Both Eyes)
-0.1 to < 0.0 logMAR
|
35 Participants
n=62 Participants
|
97 Participants
n=187 Participants
|
62 Participants
n=125 Participants
|
|
Distance Visual Acuity in Habitual Refractive Correction (Mean of Both Eyes)
0.0 to < 0.1 logMAR
|
16 Participants
n=62 Participants
|
52 Participants
n=187 Participants
|
36 Participants
n=125 Participants
|
|
Distance Visual Acuity in Habitual Refractive Correction (Mean of Both Eyes)
0.1 to < 0.2 logMAR
|
5 Participants
n=62 Participants
|
14 Participants
n=187 Participants
|
9 Participants
n=125 Participants
|
|
Mean OD and OS Flat Corneal Radius
|
43.6 Diopters squared
STANDARD_DEVIATION 1.4 • n=61 Participants • Flat corneal radius was not available for 1 patient in the placebo group.
|
43.4 Diopters squared
STANDARD_DEVIATION 1.4 • n=186 Participants • Flat corneal radius was not available for 1 patient in the placebo group.
|
43.4 Diopters squared
STANDARD_DEVIATION 1.4 • n=125 Participants • Flat corneal radius was not available for 1 patient in the placebo group.
|
|
Mean OD and OS Anterior Chamber Depth
|
3.9 millimeter
STANDARD_DEVIATION 0.2 • n=62 Participants
|
3.9 millimeter
STANDARD_DEVIATION 0.2 • n=187 Participants
|
3.8 millimeter
STANDARD_DEVIATION 0.2 • n=125 Participants
|
|
Mean OD and OS Lens Thickness
|
3.3 millimeters cubed
STANDARD_DEVIATION 0.2 • n=35 Participants • Lens thickness was not available for some patients (N=53 in atropine and N=27 in placebo) because the biometer used did not provide a lens thickness reading due to measurement difficulty.
|
3.3 millimeters cubed
STANDARD_DEVIATION 0.2 • n=107 Participants • Lens thickness was not available for some patients (N=53 in atropine and N=27 in placebo) because the biometer used did not provide a lens thickness reading due to measurement difficulty.
|
3.4 millimeters cubed
STANDARD_DEVIATION 0.2 • n=72 Participants • Lens thickness was not available for some patients (N=53 in atropine and N=27 in placebo) because the biometer used did not provide a lens thickness reading due to measurement difficulty.
|
PRIMARY outcome
Timeframe: At 24 monthsThe 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.
Outcome measures
| Measure |
Atropine Group
n=119 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=58 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>0 Diopters
|
2 Participants
|
4 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
<=-3.50 Diopters
|
0 Participants
|
0 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-3.50 to -3.00 Diopters
|
1 Participants
|
0 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-3.00 to -2.50 Diopters
|
1 Participants
|
0 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-2.50 to -2.00 Diopters
|
5 Participants
|
2 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-2.00 to -1.50 Diopters
|
8 Participants
|
7 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-1.50 to -1.00 Diopters
|
19 Participants
|
9 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-1.00 to -0.50 Diopters
|
37 Participants
|
18 Participants
|
|
Treatment Group Comparison of Change in Spherical Equivalent Refractive Error.
>-0.50 to 0.00 Diopters
|
46 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: at 24 monthsPopulation: 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit.
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.
Outcome measures
| Measure |
Atropine Group
n=119 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=58 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Primary Outcome Measure Stratified by Sex
Female
|
-0.74 Diopters
Standard Deviation 0.57
|
-0.74 Diopters
Standard Deviation 0.70
|
|
Primary Outcome Measure Stratified by Sex
Male
|
-0.84 Diopters
Standard Deviation 0.70
|
-0.75 Diopters
Standard Deviation 0.44
|
PRIMARY outcome
Timeframe: by 24 monthsPopulation: 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit.
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.
Outcome measures
| Measure |
Atropine Group
n=119 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=58 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Primary Outcome Measure Stratified by Race
More than one race
|
-0.84 Diopter
Standard Deviation 0.68
|
-0.61 Diopter
Standard Deviation 0.58
|
|
Primary Outcome Measure Stratified by Race
White
|
-0.67 Diopter
Standard Deviation 0.55
|
-0.74 Diopter
Standard Deviation 0.52
|
|
Primary Outcome Measure Stratified by Race
Black/African American
|
-0.84 Diopter
Standard Deviation 0.63
|
-1.07 Diopter
Standard Deviation 0.74
|
|
Primary Outcome Measure Stratified by Race
Asian
|
-1.18 Diopter
Standard Deviation 0.80
|
-0.26 Diopter
Standard Deviation 0.51
|
|
Primary Outcome Measure Stratified by Race
Unknown/not reported
|
-0.10 Diopter
|
—
|
PRIMARY outcome
Timeframe: at 24 monthsPopulation: 13 participants were ineligible for randomization, and 10 participants did not complete the 24-month visit.
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.
Outcome measures
| Measure |
Atropine Group
n=119 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=58 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Primary Outcome Measure Stratified by Ethnicity
Not Hispanic or Latino
|
-0.81 Diopters
Standard Deviation 0.66
|
-0.78 Diopters
Standard Deviation 0.62
|
|
Primary Outcome Measure Stratified by Ethnicity
Hispanic or Latino
|
-0.63 Diopters
Standard Deviation 0.44
|
-0.54 Diopters
Standard Deviation 0.42
|
PRIMARY outcome
Timeframe: 24 monthsThe 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.
Outcome measures
| Measure |
Atropine Group
n=119 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=58 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Primary Outcome: Mean Change in Spherical Equivalent Refractive Error at 24 Months
|
-3.64 diopters
Standard Deviation 1.46
|
-3.54 diopters
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: At 30 monthsTreatment 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.
Outcome measures
| Measure |
Atropine Group
n=118 Participants
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=57 Participants
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
<=-3.50 Diopters
|
1 Participants
|
0 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-3.50 to -3.00 Diopters
|
2 Participants
|
1 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-2.00 to -1.50 Diopters
|
8 Participants
|
6 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-0.50 to 0.00 Diopters
|
36 Participants
|
13 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>0 Diopters
|
4 Participants
|
3 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-3.00 to -2.50 Diopters
|
5 Participants
|
0 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-2.50 to -2.00 Diopters
|
5 Participants
|
3 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-1.50 to -1.00 Diopters
|
22 Participants
|
11 Participants
|
|
Treatment Group Comparison of Change From Baseline to 30 Months in Spherical Equivalent
>-1.00 to -0.50 Diopters
|
35 Participants
|
20 Participants
|
Adverse Events
Atropine Group
Placebo Group
Serious adverse events
| Measure |
Atropine Group
n=125 participants at risk
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=62 participants at risk
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
General disorders
Hospitalization
|
1.6%
2/125 • Number of events 2 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
Other adverse events
| Measure |
Atropine Group
n=125 participants at risk
0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops
Atropine: Daily 0.01% atropine eyedrops
|
Placebo Group
n=62 participants at risk
Placebo eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off placebo eyedrops
Placebo Eyedrops: Daily placebo eyedrops
|
|---|---|---|
|
Eye disorders
Visual Impairment
|
4.8%
6/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
3.2%
2/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Blepharitis
|
4.8%
6/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
1.6%
1/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Meibomian gland dysfunction
|
2.4%
3/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
4.8%
3/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Eye Pain
|
7.2%
9/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Dry Eye
|
2.4%
3/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
1.6%
1/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Hordeolum
|
1.6%
2/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
3.2%
2/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Accommodation Disorder
|
2.4%
3/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Optic Disc Drusen
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Headache
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Visual Acuity Reduced
|
1.6%
2/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Vitreous Floaters
|
1.6%
2/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Eye injury
|
0.00%
0/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
3.2%
2/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Ocular hyperaemia
|
1.6%
2/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Retinal degeneration
|
1.6%
2/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Ulcerative keratitis
|
0.00%
0/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
1.6%
1/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Foreign body in eye
|
0.00%
0/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
1.6%
1/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Meibomianitis
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Dermatitis contact
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Diplopia
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Pruritus
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Lacrimation increased
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
1.6%
1/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Chalazion
|
0.00%
0/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
1.6%
1/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Mydriasis
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Corneal Scar
|
0.80%
1/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
0.00%
0/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Eye Irritiation
|
72.0%
90/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
82.3%
51/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Photophobia
|
25.6%
32/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
27.4%
17/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Vision Blurred
|
13.6%
17/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
16.1%
10/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Allergic Conjunctivitis
|
8.0%
10/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
8.1%
5/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
|
Eye disorders
Ocular Discomfort
|
6.4%
8/125 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
8.1%
5/62 • Adverse event data was collected for the duration of the study, baseline to 30 months.
|
Additional Information
Raymond Kraker, PEDIG Coordinating Center Director
Jaeb Center for Health Research
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place