Trial Outcomes & Findings for Topical Application of Low-concentration (0.01%) Atropine on the Human Eye With Fast and Slow Myopia Progression Rate (NCT NCT03374306)

NCT ID: NCT03374306

Last Updated: 2024-10-16

Results Overview

Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 71 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2024-10-16

Participant Flow

Recruitment period: Feb 2018 - Oct 2018 Location: HK PolyU Optometry clinic

Participant milestones

Measure	Atropine 0.01% Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application	Artifical Tear Group receiving placebo for 18 months Artificial tear: tropical application
Overall Study STARTED	36	35
Overall Study COMPLETED	34	27
Overall Study NOT COMPLETED	2	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 subjects from treatment group and 8 subjects from control group withdrew from the study

Baseline characteristics by cohort

Measure	Atropine 0.01% n=36 Participants Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application	Artifical Tear n=35 Participants Group receiving placebo for 18 months Artificial tear: tropical application	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	27 Participants n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	61 Participants n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Age, Categorical Between 18 and 65 years	0 Participants n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	0 Participants n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	0 Participants n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Age, Categorical >=65 years	0 Participants n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	0 Participants n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	0 Participants n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Sex: Female, Male Female	17 Participants n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	13 Participants n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	30 Participants n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Sex: Female, Male Male	17 Participants n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	14 Participants n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	31 Participants n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Hong Kong	34 participants n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	27 participants n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	61 participants n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Refractive errors	-1.88 Dioptre STANDARD_DEVIATION 1.08 • n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	-1.74 Dioptre STANDARD_DEVIATION 0.71 • n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	-1.8 Dioptre STANDARD_DEVIATION 0.95 • n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Electroretinogram	41.65 nV/deg^2 STANDARD_DEVIATION 24.4 • n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	50.01 nV/deg^2 STANDARD_DEVIATION 27.75 • n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	45.16 nV/deg^2 STANDARD_DEVIATION 25.45 • n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study
Axial length	24.17 mm STANDARD_DEVIATION 0.79 • n=34 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	24.09 mm STANDARD_DEVIATION 0.74 • n=27 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study	24.13 mm STANDARD_DEVIATION 0.76 • n=61 Participants • 2 subjects from treatment group and 8 subjects from control group withdrew from the study

PRIMARY outcome

Timeframe: 18 months

Population: Annualized changes in refractive error (SER)

Annualized changes in refractive error (SER) after receiving the 0.01 atropine or artificial tears up to 18 months

Outcome measures

Measure	Atropine 0.01% n=34 Participants Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application	Artifical Tear n=27 Participants Group receiving placebo for 18 months Artificial tear: tropical application
Annualized Changes in Refractive Error (SER)	-0.70 Dioptre/year Standard Deviation 0.39	-0.66 Dioptre/year Standard Deviation 0.41

SECONDARY outcome

Timeframe: 18 months

Population: annualized change in axial length

Annualized change in axial length after receiving the 0.01 atropine or artificial tears up to 18 months

Outcome measures

Measure	Atropine 0.01% n=34 Participants Group receiving atropine treatment for 18 months Atropine (0.01%): tropical application	Artifical Tear n=27 Participants Group receiving placebo for 18 months Artificial tear: tropical application
Annualized Change in Axial Length	0.3 mm/year Standard Deviation 0.22	0.32 mm/year Standard Deviation 0.16

Adverse Events

Atropine 0.01%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Artifical Tear

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

Prof. Henry Chan

HK Polytechnic University

Phone: +85227667937

Email: henryhl.chan@polyu.edu.hk

Results disclosure agreements

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