Trial Outcomes & Findings for Low-dose Atropine for the Prevention of Myopia Progression in Danish Children (NCT NCT03911271)

NCT ID: NCT03911271

Last Updated: 2025-06-29

Results Overview

Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 97 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2025-06-29

Participant Flow

Danish children with myopia were referred from optometrists and ophthalmologists across Denmark. Recruitment and follow-up took place between May 2019 and April 2024 (Last patient last visit = 23 of April 2024)

Participant milestones

Measure	Loading Dose In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Overall Study STARTED	33	32	32
Overall Study COMPLETED	31	31	29
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

Baseline characteristics by cohort

Measure	Loading Dose n=33 Participants In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=32 Participants In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=32 Participants In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Total n=97 Participants Total of all reporting groups
Age, Continuous	9.5 Years n=5 Participants	9.4 Years n=7 Participants	9.2 Years n=5 Participants	9.4 Years n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	32 Participants n=7 Participants	32 Participants n=5 Participants	97 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Axial length	24.5 mm STANDARD_DEVIATION 0.86 • n=5 Participants	24.6 mm STANDARD_DEVIATION 0.78 • n=7 Participants	24.4 mm STANDARD_DEVIATION 0.90 • n=5 Participants	24.6 mm STANDARD_DEVIATION 0.84 • n=4 Participants
Spherical equivalent refraction	-3.00 Diopters STANDARD_DEVIATION 1.59 • n=5 Participants	-2.97 Diopters STANDARD_DEVIATION 1.13 • n=7 Participants	-3.07 Diopters STANDARD_DEVIATION 1.04 • n=5 Participants	-2.99 Diopters STANDARD_DEVIATION 1.27 • n=4 Participants

PRIMARY outcome

Timeframe: 36 months

Treatment group comparison of axial length at 36 months, as measured using IOLMaster 700

Outcome measures

Measure	Loading Dose n=31 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=31 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=29 Participants In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Axial Length at 36 Months	25.28 mm Interval 25.06 to 25.5	25.25 mm Interval 25.03 to 25.47	25.33 mm Interval 25.11 to 25.56

PRIMARY outcome

Timeframe: 36 months

Treatment group comparison of spherical equivalent at 36 months, as measured using cycloplegic autorefraction

Outcome measures

Measure	Loading Dose n=31 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=31 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=29 Participants In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Spherical Equivalent at 36 Months	-4.45 Diopters Interval -4.84 to -4.06	-4.26 Diopters Interval -4.65 to -3.87	-4.43 Diopters Interval -4.83 to -4.03

SECONDARY outcome

Timeframe: 36 months

Total individual adverse events per interventional arm

Outcome measures

Measure	Loading Dose n=33 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=32 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=32 Participants In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Adverse Events	104 Number of adverse events reported	22 Number of adverse events reported	18 Number of adverse events reported

SECONDARY outcome

Timeframe: 36 months

Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)

Outcome measures

Measure	Loading Dose n=33 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=32 Participants In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=32 Participants In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Change in Choroidal Thickness From Baseline to 36 Months	2 microns Interval -11.0 to 15.0	7 microns Interval -3.0 to 17.0	3 microns Interval -8.0 to 14.0

Adverse Events

Loading Dose

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Low Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Loading Dose n=33 participants at risk In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=32 participants at risk In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=32 participants at risk In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Immune system disorders Lymphadenopathy	0.00% 0/33 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	3.1% 1/32 • Number of events 1 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Nervous system disorders Suspicion of meningitis	0.00% 0/33 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	3.1% 1/32 • Number of events 1 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Gastrointestinal disorders Appendicitis	0.00% 0/33 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	3.1% 1/32 • Number of events 1 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.

Other adverse events

Measure	Loading Dose n=33 participants at risk In phase 1 (treatment phase), the participants (n=33) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Low Dose n=32 participants at risk In phase 1 (treatment phase), the participants (n=32) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.	Placebo n=32 participants at risk In phase 1 (treatment phase), the participants (n=32) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.
Eye disorders Eye redness/irritation	24.2% 8/33 • Number of events 8 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	18.8% 6/32 • Number of events 6 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	15.6% 5/32 • Number of events 5 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Eye disorders Photophobia	90.9% 30/33 • Number of events 30 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	12.5% 4/32 • Number of events 4 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	3.1% 1/32 • Number of events 1 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Eye disorders Other	42.4% 14/33 • Number of events 14 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	31.2% 10/32 • Number of events 10 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	34.4% 11/32 • Number of events 11 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Eye disorders Blurred near vision	100.0% 33/33 • Number of events 33 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	6.2% 2/32 • Number of events 2 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	3.1% 1/32 • Number of events 1 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Eye disorders Blurred distance vision	0.00% 0/33 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.
Eye disorders Dilated pupils	57.6% 19/33 • Number of events 19 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.	0.00% 0/32 • From enrollment to three years The intent is to report the total number of adverse events AND reactions. Adverse events and reactions that are considered normal reactions to an eye examination (including stinging when applying eye drops for the examinations and short-term photophobia and blurred vision following eye examination) was not considered an AE/AR. Examples of adverse events that are exempted from registration includes conditions that are common to normal child development and child life were not reported.

Additional Information

Niklas Cyril Hansen MD-PhD

Rigshospitalet-Glostrup

Phone: +45 31433244

Email: niklas.cyril.hansen@regionh.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place