MyopiaPhase 2/3NCT07164092
Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center
A Phase 2/3 study testing Atropine 0.05% Eye drops in people with Myopia, run by Mansoura University.
Trial summary
This randomized controlled trial aims to evaluate the efficacy and safety of low-dose topical atropine sulphate (0.05%), a non-selective muscarinic antagonist, in slowing the progression of myopia and ocular axial elongation in children. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine 0.05% Eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Myopia of at least -1.0 D in both eyes, astigmatism of less than 2.0 D, anisometropia of objective spherical equivalent ≤ 1.50 D.
- Documented myopic progression of at least 0.5 D in the past one year.
Who cannot join
- Children with ocular or systemic diseases that potentially influence myopia or refractive power.
- Ocular diseases, e.g., cataracts, glaucoma
- Posterior segment hereditary and acquired pathological disorders.
- History of any previous ocular surgery.
- History of any ocular injuries.
- Previous use of interventions (such as atropine, pirenzepine, orthokeratology lens, or other optical methods) for myopia control
- Allergy to atropine, cyclopentolate or benzalkonium chloride
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled trial aims to evaluate the efficacy and safety of low-dose topical atropine sulphate (0.05%), a non-selective muscarinic antagonist, in slowing the progression of myopia and ocular axial elongation in children. The study will be conducted at Mansoura Ophthalmic Center, Mansoura University, Egypt, from October 2025 to october 2027.
Eligible participants are myopic children attending the outpatient clinic during the study period. Participants will be stratified into three groups according to baseline myopia severity (low, moderate, and high). Each child will be randomized to receive one drop of atropine 0.05% in one eye and one drop of placebo in the fellow eye nightly for 24 months. The allocation of treatment to right or left eye will be randomized to avoid laterality bias.
Read more
Study Outcomes
- Primary Outcome
- Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation.
- Secondary Outcomes
- Change in spherical equivalent refraction (SER), measured by cycloplegic autorefraction using a Topcon KR-800 autorefractor after standard cycloplegia with cyclopentolate 1%.
- Best-corrected distance visual acuity (BCVA).
- Sample Size
The primary endpoint of this trial is the change in ocular axial length (AL) over 24 months, analyzed as a paired comparison between the atropine-treated and placebo-treated eyes within each child.
Sample size estimation was based on previously published data reporting mean axial elongation of 0.115 ± 0.11 mm in atropine-treated eyes compared with 0.303 ± 0.12 mm in placebo-treated eyes, yielding a mean difference of 0.188 mm. Assuming an inter-eye correlation of 0.6, the standard deviation of the paired difference is estimated at approximately 0.10 mm, giving an effect size of d = 1.88. Using a two-tailed paired t-test with α = 0.05 and 90% power, the minimum required sample size is 12 children.
- Conditions
- Myopia
- Being tested
- Atropine 0.05% Eye drops, Placebo ophthalmic solution
- Keywords
- Atropine, Myopia, Axial elongation
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0.05% Eye dropsDrug
The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months.
Placebo ophthalmic solutionDrug
The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.05% Eye | Experimental | The randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months. Receives: Drug: Atropine 0.05% Eye drops |
| Placebo Eye | Placebo comparator | The fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months. Receives: Drug: Placebo ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ocular axial length (AL)
Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation
Measured: 2 years
Secondary outcomes (2)
Change in spherical equivalent refraction (SER
Change in spherical equivalent refraction (SER), measured by cycloplegic autorefraction using a Topcon KR-800 autorefractor after standard cycloplegia with cyclopentolate 1%.
Measured: 24 months
Best-corrected distance visual acuity (BCVA).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will receive one drop of atropine 0.05% in one randomly assigned eye and one drop of placebo in the fellow eye nightly for 24 months. No other myopia control treatments will be permitted during the study period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Allam, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164092
- Sponsor's protocol ID
- Atropine ED for Myopia in MOC
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I have not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Atropine Eye Drops for Control of Myopia Progression Among Children Attending Mansoura University Ophthalmic Center
- ClinicalTrials.gov ID
- NCT07164092
- Acronym / sponsor ID
- Atropine ED for Myopia in MOC
- Conditions
- Myopia
- Keywords
- Atropine, Myopia, Axial elongation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 9 Sep 2025 (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.
This randomized controlled trial aims to evaluate the efficacy and safety of low-dose topical atropine sulphate (0.05%), a non-selective muscarinic antagonist, in slowing the progression of myopia and ocular axial elongation in children. The study will be conducted at Mansoura Ophthalmic Center, Mansoura University, Egypt, from October 2025 to october 2027.
Eligible participants are myopic children attending the outpatient clinic during the study period. Participants will be stratified into three groups according to baseline myopia severity (low, moderate, and high). Each child will be randomized to receive one drop of atropine 0.05% in one eye and one drop of placebo in the fellow eye nightly for 24 months. The allocation of treatment to right or left eye will be randomized to avoid laterality bias.
Study Outcomes
- Primary Outcome
- Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation.
- Secondary Outcomes
- Change in spherical equivalent refraction (SER), measured by cycloplegic autorefraction using a Topcon KR-800 autorefractor after standard cycloplegia with cyclopentolate 1%.
- Best-corrected distance visual acuity (BCVA).
- Sample Size
The primary endpoint of this trial is the change in ocular axial length (AL) over 24 months, analyzed as a paired comparison between the atropine-treated and placebo-treated eyes within each child.
Sample size estimation was based on previously published data reporting mean axial elongation of 0.115 ± 0.11 mm in atropine-treated eyes compared with 0.303 ± 0.12 mm in placebo-treated eyes, yielding a mean difference of 0.188 mm. Assuming an inter-eye correlation of 0.6, the standard deviation of the paired difference is estimated at approximately 0.10 mm, giving an effect size of d = 1.88. Using a two-tailed paired t-test with α = 0.05 and 90% power, the minimum required sample size is 12 children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will receive one drop of atropine 0.05% in one randomly assigned eye and one drop of placebo in the fellow eye nightly for 24 months. No other myopia control treatments will be permitted during the study period.
| Arm | Type | Receives |
|---|---|---|
| Atropine 0.05% Eye | Experimental | Drug: Atropine 0.05% Eye dropsThe randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months. |
| Placebo Eye | Placebo comparator | Drug: Placebo ophthalmic solutionThe fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Myopia of at least -1.0 D in both eyes, astigmatism of less than 2.0 D, anisometropia of objective spherical equivalent ≤ 1.50 D.
- Documented myopic progression of at least 0.5 D in the past one year.
Key exclusion criteria (7 listed)
- Children with ocular or systemic diseases that potentially influence myopia or refractive power.
- Ocular diseases, e.g., cataracts, glaucoma
- Posterior segment hereditary and acquired pathological disorders.
- History of any previous ocular surgery.
- History of any ocular injuries.
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 0.05% Eye dropsThe randomized eye will receive one drop of atropine sulphate 0.05% nightly for 24 months. | Drug | Atropine 0.05% Eye |
| Placebo ophthalmic solutionThe fellow eye will receive one drop of placebo (vehicle solution without active drug) nightly for 24 months. | Drug | Placebo Eye |
Primary outcome
Change in ocular axial length (AL)
Time frame: 2 years
Change in ocular axial length (AL) from baseline to 24 months, measured with a NIDEK AL-scan optical biometer (average of five readings within a deviation of ≤0.05 mm). This parameter was used for sample size estimation
2 secondary outcomes
Change in spherical equivalent refraction (SER
Time frame: 24 months
Best-corrected distance visual acuity (BCVA).
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Undecided. I have not decided yet
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Atropine 0.05% Eye drops in people with Myopia, run by Mansoura University.
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 7 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: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghada H. Allam, Dr (+201062838323, drghada_allam@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ocular axial length (AL) (time frame: 2 years). 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 9 Sep 2025.