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

NCT07626892 | Completed Phase 3

• 1 other identifier: 303/IREB/KTH
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myopia; progressive myopia; myopia control; low dose atropine; atropine 0.01%; atropine 0.03%; atropine 0.05%; axial length; spherical equivalent; spherical equivalent refraction; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Change in spherical equivalent refraction (SER)

  Change in spherical equivalent refraction (SER) measured with autorefractometer

  18 months

• Change in axial length (AL)

  Change in axial length (AL) measured with IOL master

  18 months

Secondary Outcomes (1)

• Frequency and type of ocular and systemic adverse effects

  18 months

Study Arms (3)

Group A will receive Atropine sulphate 0.01% eye drops

ACTIVE COMPARATOR

Atropine sulphate 0.01% eye drops1 drop once daily at bedtime

Drug: Atropine sulphate eye drop 0.01%

Group B will receive Atropine sulphate 0.03% eye drops

ACTIVE COMPARATOR

Atropine sulphate 0.03% eye drops1 drop once daily at bedtime

Drug: Atropine sulphate eye drop 0.03%

Group C will receive Atropine sulphate 0.05% eye drops

ACTIVE COMPARATOR

Atropine sulphate 0.05% eye drops1 drop once daily at bedtime

Drug: Atropine sulphate eye drop 0.05%

Interventions

Atropine sulphate eye drop 0.01% DRUG

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.

Also known as: Ophth atropine eye drop 0.01%

Group A will receive Atropine sulphate 0.01% eye drops

Atropine sulphate eye drop 0.03% DRUG

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.

Also known as: Ophth atropine eye drop 0.03%

Group B will receive Atropine sulphate 0.03% eye drops

Atropine sulphate eye drop 0.05% DRUG

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.

Also known as: Ophth atropine eye drop 0.05%

Group C will receive Atropine sulphate 0.05% eye drops

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 6-18 years.
• SER between -1.00 and -6.00 diopters.

You may not qualify if:

• History of ocular surgery or trauma.
• Use of other myopia control interventions in the last 6 months.
• Allergies to atropine.

Sponsors & Collaborators

• Khyber Medical College, Peshawar: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Myopia; Myopia, Degenerative

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Nazli Gul, FCPS

  Khyber Medical College/ Khyber Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 3, 2024
• Primary Completion: May 22, 2026
• Study Completion: May 22, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Available after the publication of the paper for 1 year
• Access Criteria: The principal investigator will review requests of IPD sharing. A signed data-sharing agreement will be required to ensure protection of participant confidentiality and compliance with ethical and institutional regulations. Data will be shared only in de-identified form, with no direct or indirect identifiers. Access will be granted for scientifically valid proposals only.

Locations

PA (1)