MyopiaPhase 3STAMPNCT05529056
Study of Atropine Therapeutic Effect on Myopic Progression
A Phase 3 study testing Atropine Sulfate 01, Atropine Sulfate 02 and Atropine Sulfate 03 in people with Myopia and Children, run by LitePharmTech Co., Ltd. at 15 sites in South Korea.
Trial summary
This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- What is being tested?
- Atropine Sulfate 01, Atropine Sulfate 02 and Atropine Sulfate 03
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 25 May 2022to 31 Dec 2023
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 5 to 12 years at the time of consent
- Refractive error of SE at least -1.0 D and no greater than -8.0 D in both eyes as measured by cycloplegic autorefraction at visit 1 and visit 2.
- Confirmed myopia progression of 0.5D or more within past 1year
- Astigmatism of 2.5D or less in both eyes
- Distance Best Corrective Visual Acuity to logMAR 0.2 or better in both eyes at visit1.
- Normal IOP under 21mmHg in both eyes.
- Anisometropia of SE less than 2.0D as measured by cycloplegic autorefraction at visit 1.
- Written informed consent willingly obtained by both subject and his/her parents
Who cannot join
- Hypersensitivity to atropine or other cycloplegic agent.
- History of the surgery of refractive correction
- Having ocular disease affect to visual function or refractive error: history of glaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence of conjunctivitis at screening visit.
- Having systemic diseases that affect to vision loss
- Having risk of IOP elevation such as narrow angle, Shallow Anterior Chambers, etc
- Presence of binocular function disorder or stereopsis disorder
Show all 14Show fewer
- Amblyopia or manifest strabismus
- History of premature birth(less than 37weeks) or low birth weight(less than 2,500g)
- Previous or current use of atropine or Ortho-K lens for myopia
- Down syndrome, spastic paralysis, brain damage, spastic palsy, bladder
- Presence of neurological diseases like epilepsy, etc. which could expect difficulties in compliant to the ocular examinations.
- Presence of clinically significant cardiac and respiratory diseases
- Participation in any other clinical study of an investigational product within 3-month prior to current IP administration.
- Based on the investigator's discretion, subject who is not proper to participate in the trial.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites, 15 recruiting
- Recruiting
Pusan National University Hospital
Busan, 49241
Choi
- Recruiting
Inje University Busan Paik Hospital
Busan
Moon
- Recruiting
Kangwon National University Hospital
Chuncheon
Yoo
- Recruiting
Chungnam National University Hospital
Daejeon
Lee
- Recruiting
Chung-Ang University Gwang Myeong hospital
Gwangmyeong
Kim
- Recruiting
Gachon University Gil Hospital
Incheon, 21565
Paik
- Recruiting
HanGil Eye Hospital
Incheon
Kim
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si
Yang
- Recruiting
Kim'S Eye Hospital
Seoul, 07301
Baek
- Recruiting
Samsung Medical Center
Seoul
Oh
- Recruiting
Seoul Asan Medical Center
Seoul
Lee
- Recruiting
Seoul National University Hospital
Seoul
Kim
- Recruiting
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Shin
- Recruiting
Ajou University Hospital
Suwon
Chung
- Recruiting
Yongin Severance Hospital
Yŏngin
Seo
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia
This study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.
Read the detailed description
The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.
- Being tested
- Atropine Sulfate 01, Atropine Sulfate 02, Atropine Sulfate 03, Placebo
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine Sulfate 01Drug
Also called LPTAT01
Atropine sulfate 01 ophthalmic solution
Atropine Sulfate 02Drug
Also called LPTAT02
Atropine sulfate 02 ophthalmic solution
Atropine Sulfate 03Drug
Also called LPTAT03
Atropine sulfate 03 ophthalmic solution
PlaceboDrug
Also called LPTAT04
Placebo ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| Test Arm 1 | Experimental | LPTAT01 Receives: Drug: Atropine Sulfate 01 |
| Test Arm 2 | Experimental | LPTAT02 Receives: Drug: Atropine Sulfate 02 |
| Test Arm 3 | Experimental | LPTAT03 Receives: Drug: Atropine Sulfate 03 |
| Reference Arm | Placebo comparator | LPTAT04 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Spherical Equivalent over 12-month
Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline
Measured: 12 months
Secondary outcomes (2)
Change in Spherical Equivalent
Change in spherical equivalent measured by cycloplegic autorefraction at 4, 8 months after administration of clinical trial drug compared to baseline
Measured: 4, 8 months
Change in Axial length (mm)
Change in Axial length (mm) at 4, 8, 12 months after administration of clinical trial drug compared to baseline
Measured: 4, 8, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start25 May 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LitePharmTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sei Yeul Oh, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529056
- Sponsor's protocol ID
- LPT-01
- Acronym
- STAMP
- Status last verified
- Feb 2023
- First submitted
- 10 Aug 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Therapeutic Effect and Safety of LPTAT in Children With Myopia
- ClinicalTrials.gov ID
- NCT05529056
- Acronym / sponsor ID
- STAMP / LPT-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- LitePharmTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Sep 2022 (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 study is to evaluate the therapeutic effect and safety of LPTAT in children with myopia.
Detailed description
The primary objective is to evaluate the superiority of LPTAT to placebo in slowing myopia progression through the change of SE(Spherical Equivalent), which is measured by cycloplegic autorefraction after 12-month treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Arm 1 | Experimental | Drug: Atropine Sulfate 01LPTAT01 |
| Test Arm 2 | Experimental | Drug: Atropine Sulfate 02LPTAT02 |
| Test Arm 3 | Experimental | Drug: Atropine Sulfate 03LPTAT03 |
| Reference Arm | Placebo comparator | Drug: PlaceboLPTAT04 |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Aged 5 to 12 years at the time of consent
- Refractive error of SE at least -1.0 D and no greater than -8.0 D in both eyes as measured by cycloplegic autorefraction at visit 1 and visit 2.
- Confirmed myopia progression of 0.5D or more within past 1year
- Astigmatism of 2.5D or less in both eyes
- Distance Best Corrective Visual Acuity to logMAR 0.2 or better in both eyes at visit1.
Key exclusion criteria (14 listed)
- Hypersensitivity to atropine or other cycloplegic agent.
- History of the surgery of refractive correction
- Having ocular disease affect to visual function or refractive error: history of glaucoma, macula r degeneration, diabetic eye disease, uveitis, etc, or presence of conjunctivitis at screening visit.
- Having systemic diseases that affect to vision loss
- Having risk of IOP elevation such as narrow angle, Shallow Anterior Chambers, etc
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 Sulfate 01Also: LPTAT01Atropine sulfate 01 ophthalmic solution | Drug | Test Arm 1 |
| Atropine Sulfate 02Also: LPTAT02Atropine sulfate 02 ophthalmic solution | Drug | Test Arm 2 |
| Atropine Sulfate 03Also: LPTAT03Atropine sulfate 03 ophthalmic solution | Drug | Test Arm 3 |
| PlaceboAlso: LPTAT04Placebo ophthalmic solution | Drug | Reference Arm |
Primary outcome
Change in Spherical Equivalent over 12-month
Time frame: 12 months
Change in spherical equivalent measured by cycloplegic autorefraction at 12 months after administration of clinical trial drug compared to baseline
2 secondary outcomes
Change in Spherical Equivalent
Time frame: 4, 8 months
Change in Axial length (mm)
Time frame: 4, 8, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Sei Yeul Oh principal investigator
Samsung Medical Center
15 sites 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 Sulfate 01, Atropine Sulfate 02 and Atropine Sulfate 03 in people with Myopia and Children, run by LitePharmTech Co., Ltd. at 15 sites in South Korea.
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 8 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in South Korea. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GH KIM (82-70-8805-9682, ghkim@litepharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spherical Equivalent over 12-month (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 23 Feb 2023.