MedTrace Logo

Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression

NCT07626892 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-06-10

No results posted yet for this study

Summary

Myopia is one of the fastest-growing ocular disorders worldwide and has become a major public health concern, especially among children and adolescents. Progressive myopia is clinically significant because it increases the lifetime risk of serious ocular complications such as retinal detachment, glaucoma, cataract, and myopic maculopathy. Even a small increase in refractive error has been shown to increase the risk of irreversible visual impairment, highlighting the need for effective strategies to slow myopia progression during childhood.

Atropine eye drops have emerged as one of the most effective pharmacological interventions for myopia control. Although high-dose atropine (1%) significantly slows myopia progression, its use is limited by adverse effects such as photophobia, blurred near vision, and poor tolerability. Recent landmark studies, including the Atropine for the Treatment of Myopia (ATOM) and Low-Concentration Atropine for Myopia Progression (LAMP) trials, demonstrated that lower concentrations of atropine (0.01%, 0.03%, and 0.05%) can effectively reduce myopia progression with fewer side effects. However, uncertainty remains regarding the optimal atropine concentration that provides the best balance between efficacy and safety, particularly in South Asian populations where local evidence is limited.

This study aims to compare the efficacy and safety of 0.01%, 0.03%, and 0.05% atropine eye drops in controlling myopia progression among children aged 6-18 years in Pakistan. The research question investigates whether these atropine concentrations differ in reducing myopia progression as measured by changes in spherical equivalent refraction (SER) and axial length (AL) over the study period.

Conditions

  • Myopia Progression
  • Atropine

Interventions

DRUG

Atropine sulphate eye drop 0.01%

Topical atropine sulfate ophthalmic solution 0.01% administered as one drop in each eye once daily at bedtime for 18 months for control of myopia progression in children. Participants will be monitored regularly for efficacy (SER and axial length) and adverse effects. No other pharmacologic myopia control treatment will be allowed during the study period.

DRUG

Atropine sulphate eye drop 0.03%

Topical atropine sulfate ophthalmic solution 0.03% administered as one drop in each eye once daily at bedtime for 18 months for control of myopia progression in children. Participants will be monitored regularly for efficacy (SER and axial length) and adverse effects. No other pharmacologic myopia control treatment will be allowed during the study period.

DRUG

Atropine sulphate eye drop 0.05%

Topical atropine sulfate ophthalmic solution 0.05% administered as one drop in each eye once daily at bedtime for 18 months for control of myopia progression in children. Participants will be monitored regularly for efficacy (SER and axial length) and adverse effects. No other pharmacologic myopia control treatment will be allowed during the study period.

Sponsors & Collaborators

  • Khyber Medical College, Peshawar

    lead OTHER

Principal Investigators

  • Nazli Gul, FCPS · Khyber Medical College/ Khyber Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-03
Primary Completion
2026-05-22
Completion
2026-05-22

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626892 on ClinicalTrials.gov