Myopia ProgressionPhase 3NCT07626892
Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression
A Phase 3 study testing Atropine sulphate eye drop 0.01%, Atropine sulphate eye drop 0.03% and Atropine sulphate eye drop 0.05% in people with Myopia Progression and Atropine, run by Khyber Medical College, Peshawar at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Myopia Progression, Atropine
- What is being tested?
- Atropine sulphate eye drop 0.01%, Atropine sulphate eye drop 0.03% and Atropine sulphate eye drop 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Jun 2024to 22 May 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children aged 6-18 years.
- SER between -1.00 and -6.00 diopters.
Who cannot join
- History of ocular surgery or trauma.
- Use of other myopia control interventions in the last 6 months.
- Allergies to atropine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression: A Randomized Controlled Trial
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.
Read the detailed description
The primary objective is to evaluate and compare the effectiveness of the three atropine concentrations in slowing myopia progression and to assess their safety profiles. The independent variable is the concentration of atropine eye drops, while the dependent variables include changes in SER and AL. Safety outcomes include the frequency and severity of ocular side effects such as photophobia, irritation, near blur, and pupillary dilatation, as well as systemic side effects including dry mouth, flushing, and tachycardia.
This prospective randomized open-label blinded endpoint (PROBE) trial will be conducted at the Department of Ophthalmology, Khyber Teaching Hospital, Peshawar, after approval from the Ethical Review Board of Khyber Medical College. The study duration will extend from June 2024 to December 2026. Written informed consent will be obtained from parents or guardians prior to enrollment.
Children aged 6-18 years with myopia ranging from -1.00 to -6.00 diopters will be recruited through pediatric ophthalmology and optometry outpatient services using consecutive non-probability sampling. Participants will undergo baseline ophthalmic assessment, including cycloplegic autorefraction, SER calculation, axial length measurement using Zeiss IOL Master, keratometry readings, best-corrected visual acuity assessment, and anterior and posterior segment examination. Demographic details such as age and gender will also be recorded.
Participants will be randomly allocated in a 1:1:1 ratio into three treatment groups using block randomization with allocation concealment. Group A will receive 0.01% atropine eye drops, Group B will receive 0.03% atropine, and Group C will receive 0.05% atropine, administered once daily at bedtime throughout the study period.
Follow-up visits will occur at baseline, 4 months, 8 months, 12 months, and 18 months. At each visit, SER, AL, keratometry readings, visual acuity, treatment adherence, and adverse events will be assessed. The primary outcomes will be changes in SER and axial length over 18 months, while secondary outcomes will include the frequency and type of ocular and systemic adverse effects associated with each atropine concentration.
Children with a history of ocular trauma or surgery, recent use of other myopia control interventions, or known atropine allergy will be excluded. The calculated sample size is 95 participants, distributed approximately equally among the three groups.
Statistical analysis will be performed using linear mixed-effects models to compare mean changes in SER and AL over time between groups while accounting for repeated measurements. Post hoc pairwise comparisons with Bonferroni correction will be applied when appropriate. Safety outcomes will be analyzed using chi-square or Fisher's exact tests. Multivariate regression analysis will also be performed to adjust for potential confounding variables such as age, baseline refractive error, axial length, and parental myopia.
This study is expected to provide locally relevant evidence regarding the most effective and safest low-dose atropine concentration for myopia control in Pakistani children and may contribute to future clinical guidelines for pediatric myopia management.
- Conditions
- Myopia Progression, Atropine
- Being tested
- Atropine sulphate eye drop 0.01%, Atropine sulphate eye drop 0.03%, Atropine sulphate eye drop 0.05%
- 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
- Medical subject headings
- Myopia, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine sulphate eye drop 0.01%Drug
Also called Ophth atropine 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.
Atropine sulphate eye drop 0.03%Drug
Also called Ophth atropine 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.
Atropine sulphate eye drop 0.05%Drug
Also called Ophth atropine 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A will receive Atropine sulphate 0.01% eye drops | Active comparator | Atropine sulphate 0.01% eye drops1 drop once daily at bedtime Receives: 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 Receives: 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 Receives: Drug: Atropine sulphate eye drop 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spherical equivalent refraction (SER)
Change in spherical equivalent refraction (SER) measured with autorefractometer
Measured: 18 months
Change in axial length (AL)
Change in axial length (AL) measured with IOL master
Measured: 18 months
Secondary outcomes (1)
Frequency and type of ocular and systemic adverse effects
Frequency and type of ocular and systemic adverse effects associated with each atropine concentration
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start3 Jun 2024
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Medical College, Peshawar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nazli Gul, Khyber Medical College, Peshawar
- Investigators
- Nazli Gul, FCPS, Principal investigator, Khyber Medical College/ Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626892
- Sponsor's protocol ID
- 303/IREB/KTH
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD including baseline characteristics, spherical equivalent refraction, axial length measurements, keratometry readings, and adverse event data, will be made available upon reasonable request after publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 0.01%, 0.03%, and 0.05% Atropine Eye Drops in Reducing Myopia Progression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07626892
- Acronym / sponsor ID
- 303/IREB/KTH
- Conditions
- Myopia Progression, Atropine
- Keywords
- myopia, progressive myopia, myopia control, low dose atropine, atropine 0.01%, atropine 0.03%, atropine 0.05%, axial length
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Khyber Medical College, PeshawarUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective is to evaluate and compare the effectiveness of the three atropine concentrations in slowing myopia progression and to assess their safety profiles. The independent variable is the concentration of atropine eye drops, while the dependent variables include changes in SER and AL. Safety outcomes include the frequency and severity of ocular side effects such as photophobia, irritation, near blur, and pupillary dilatation, as well as systemic side effects including dry mouth, flushing, and tachycardia.
This prospective randomized open-label blinded endpoint (PROBE) trial will be conducted at the Department of Ophthalmology, Khyber Teaching Hospital, Peshawar, after approval from the Ethical Review Board of Khyber Medical College. The study duration will extend from June 2024 to December 2026. Written informed consent will be obtained from parents or guardians prior to enrollment.
Children aged 6-18 years with myopia ranging from -1.00 to -6.00 diopters will be recruited through pediatric ophthalmology and optometry outpatient services using consecutive non-probability sampling. Participants will undergo baseline ophthalmic assessment, including cycloplegic autorefraction, SER calculation, axial length measurement using Zeiss IOL Master, keratometry readings, best-corrected visual acuity assessment, and anterior and posterior segment examination. Demographic details such as age and gender will also be recorded.
Participants will be randomly allocated in a 1:1:1 ratio into three treatment groups using block randomization with allocation concealment. Group A will receive 0.01% atropine eye drops, Group B will receive 0.03% atropine, and Group C will receive 0.05% atropine, administered once daily at bedtime throughout the study period.
Follow-up visits will occur at baseline, 4 months, 8 months, 12 months, and 18 months. At each visit, SER, AL, keratometry readings, visual acuity, treatment adherence, and adverse events will be assessed. The primary outcomes will be changes in SER and axial length over 18 months, while secondary outcomes will include the frequency and type of ocular and systemic adverse effects associated with each atropine concentration.
Children with a history of ocular trauma or surgery, recent use of other myopia control interventions, or known atropine allergy will be excluded. The calculated sample size is 95 participants, distributed approximately equally among the three groups.
Statistical analysis will be performed using linear mixed-effects models to compare mean changes in SER and AL over time between groups while accounting for repeated measurements. Post hoc pairwise comparisons with Bonferroni correction will be applied when appropriate. Safety outcomes will be analyzed using chi-square or Fisher's exact tests. Multivariate regression analysis will also be performed to adjust for potential confounding variables such as age, baseline refractive error, axial length, and parental myopia.
This study is expected to provide locally relevant evidence regarding the most effective and safest low-dose atropine concentration for myopia control in Pakistani children and may contribute to future clinical guidelines for pediatric myopia management.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A will receive Atropine sulphate 0.01% eye drops | Active comparator | Drug: Atropine sulphate eye drop 0.01%Atropine sulphate 0.01% eye drops1 drop once daily at bedtime |
| Group B will receive Atropine sulphate 0.03% eye drops | Active comparator | Drug: Atropine sulphate eye drop 0.03%Atropine sulphate 0.03% eye drops1 drop once daily at bedtime |
| Group C will receive Atropine sulphate 0.05% eye drops | Active comparator | Drug: Atropine sulphate eye drop 0.05%Atropine sulphate 0.05% eye drops1 drop once daily at bedtime |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children aged 6-18 years.
- SER between -1.00 and -6.00 diopters.
Key exclusion criteria (3 listed)
- History of ocular surgery or trauma.
- Use of other myopia control interventions in the last 6 months.
- Allergies to atropine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atropine sulphate eye drop 0.01%Also: Ophth atropine 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 | Group A will receive Atropine sulphate 0.01% eye drops |
| Atropine sulphate eye drop 0.03%Also: Ophth atropine 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 | Group B will receive Atropine sulphate 0.03% eye drops |
| Atropine sulphate eye drop 0.05%Also: Ophth atropine 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. | Drug | Group C will receive Atropine sulphate 0.05% eye drops |
Primary outcome
Change in spherical equivalent refraction (SER)
Time frame: 18 months
Change in spherical equivalent refraction (SER) measured with autorefractometer
Change in axial length (AL)
Time frame: 18 months
Change in axial length (AL) measured with IOL master
1 secondary outcome
Frequency and type of ocular and systemic adverse effects
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD including baseline characteristics, spherical equivalent refraction, axial length measurements, keratometry readings, and adverse event data, will be made available upon reasonable request after publication of the primary study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazli Gul, FCPS principal investigator
Khyber Medical College/ Khyber Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine sulphate eye drop 0.01%, Atropine sulphate eye drop 0.03% and Atropine sulphate eye drop 0.05% in people with Myopia Progression and Atropine, run by Khyber Medical College, Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spherical equivalent refraction (SER) (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.