MyopiaPhase 2NCT06765603
Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression
A Phase 2 study testing Atropine 0.025%, Multizonal contact lens and Single vision Contact lens in people with Myopia, run by Singapore National Eye Centre.
Trial summary
The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- Myopia
- What is being tested?
- Atropine 0.025%, Multizonal contact lens and Single vision Contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 31 Dec 2029
- Phase
- Phase 2
- 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 7 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 7 and 12 (inclusive) years of age at the time of screening.
- spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.
- Refractive cylinder less than 1.12 D (inclusive)
- Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.
- Have normal eyes (i.e., no ocular medications or infections of any type).
Who cannot join
- Past or current use of myopia control treatment or involvement in previous myopia control study
- Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).
- hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.
- previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
- Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit-lamp findings (eg. edema, corneal neovascularization, corneal staining, conjunctival injection) on the ISO 11980 classification scale.
- Any central corneal scar or corneal distortion resulting from ocular diseases or previous hard or rigid permeable contact lens wear.
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
The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.
Read the detailed description
see above
- Conditions
- Myopia
- Being tested
- Atropine 0.025%, Multizonal contact lens, Placebo, Single vision Contact lens
- Keywords
- myopia intervention
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine 0.025%Drug
Atropine 0.025%
Multizonal contact lensDevice
Multizonal CL
PlaceboDrug
Placebo
Single vision Contact lensDevice
Single vision contact lens
| Study group | Role | What they receive |
|---|---|---|
| Atropine - SVCL | Experimental | Atropine 0.025% Receives: Drug: Atropine 0.025%; Device: Single vision Contact lens |
| Atropine- multizonal CL | Active comparator | Atropine 0.025% and multizonal CL Receives: Drug: Atropine 0.025%; Device: Multizonal contact lens |
| Multizonal CL - placebo drop | Active comparator | Multizonal CL Receives: Device: Multizonal contact lens; Drug: Placebo |
| Placebo drop and SVCL | Placebo comparator | Placebo Receives: Drug: Placebo; Device: Single vision Contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spherical equivalent
Change in spherical equivalent at 12 months
Measured: 12 months
Secondary outcomes (1)
Change in axial length
Change in axial length at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Audrey Wei-Lin Chia, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765603
- Sponsor's protocol ID
- R1867/109/2021
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of the Combination of Multi-zonal Contact Lens and Atropine for Controlling Myopia Progression
- ClinicalTrials.gov ID
- NCT06765603
- Acronym / sponsor ID
- R1867/109/2021
- Conditions
- Myopia
- Keywords
- myopia intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Jan 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.
The aim of the study is to explore efficacy of combination Atropine and multifocal CL. Randomized Control Trial including 4 arms: Atropine / multizonal CL; Atropine/ SV CL, Placebo drop/ multizonal CL; Placebo drop/ SV CL. Followed over 1 year with outcome measure of change in spherical equivalent and axial length.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Atropine - SVCL | Experimental | Drug: Atropine 0.025%, Device: Single vision Contact lensAtropine 0.025% |
| Atropine- multizonal CL | Active comparator | Drug: Atropine 0.025%, Device: Multizonal contact lensAtropine 0.025% and multizonal CL |
| Multizonal CL - placebo drop | Active comparator | Device: Multizonal contact lens, Drug: PlaceboMultizonal CL |
| Placebo drop and SVCL | Placebo comparator | Drug: Placebo, Device: Single vision Contact lensPlacebo |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 7 and 12 (inclusive) years of age at the time of screening.
- spherical equivalent of cycloplegic objective refraction (by autorefraction) range of -0.75 D to -4.50 D (inclusive) in each eye.
- Refractive cylinder less than 1.12 D (inclusive)
- Best-corrected visual acuity (BCVA) of 0.04 logMAR or better in each eye, with difference less than 0.20 logMAR between eyes.
- Have normal eyes (i.e., no ocular medications or infections of any type).
Key exclusion criteria (7 listed)
- Past or current use of myopia control treatment or involvement in previous myopia control study
- Any current or seasonal use of ocular medication (eg. for allergy or chronic blepharitis).
- hypersensitivity or allergic reaction to atropine, cyclopentolate, topical anesthetics or study approved rewetting drop solutions available in local markets.
- previous history or signs of a contact lens-related corneal inflammatory event (e.g., past ulcer or scar) that may contraindicate contact lens wear.
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension, glaucoma, history of recurrent corneal erosions, aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal degeneration.
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 0.025%Atropine 0.025% | Drug | Atropine - SVCL, Atropine- multizonal CL |
| Multizonal contact lensMultizonal CL | Device | Atropine- multizonal CL, Multizonal CL - placebo drop |
| PlaceboPlacebo | Drug | Multizonal CL - placebo drop, Placebo drop and SVCL |
| Single vision Contact lensSingle vision contact lens | Device | Atropine - SVCL, Placebo drop and SVCL |
Primary outcome
Change in spherical equivalent
Time frame: 12 months
Change in spherical equivalent at 12 months
1 secondary outcome
Change in axial length
Time frame: 12 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 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atropine 0.025%, Multizonal contact lens and Single vision Contact lens in people with Myopia, run by Singapore National Eye Centre.
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 5 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 Jan 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 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.
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 audrey chia, PhD (65 62277255, audrey.chia.w.l@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spherical equivalent (time frame: 12 months). 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 Jan 2025.