MyopiaPhase 2NCT03329638
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
A Phase 2 study testing DE-127 Ophthalmic Solution low dose, DE-127 Ophthalmic Solution medium dose and DE-127 Ophthalmic Solution high dose in people with Myopia, run by Santen Pharmaceutical Co., Ltd. at 1 site in Singapore.
Trial summary
To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia. To investigate the dose response of DE-127. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia
- What is being tested?
- DE-127 Ophthalmic Solution low dose, DE-127 Ophthalmic Solution medium dose and DE-127 Ophthalmic Solution high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Oct 2017to 9 Apr 2020
- Phase
- Phase 2
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes
- Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes
- Distance vision correctable to logMAR 0.2 or better in both eyes
- Normal intraocular pressure of not greater than 21 mmHg in both eyes
- No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
Who cannot join
- Amblyopia or manifest strabismus including intermittent tropia
- Ocular disorders that potentially affect myopia or refractive power
- Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia
- Systemic disorders that potentially affect myopia or refractive power
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution Compared With Placebo in Subjects With Mild or Moderate Myopia (APPLE)
To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia.
To investigate the dose response of DE-127.
- Conditions
- Myopia
- Being tested
- DE-127 Ophthalmic Solution low dose, DE-127 Ophthalmic Solution medium dose, DE-127 Ophthalmic Solution high dose, Placebo Ophthalmic Solution
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-127 Ophthalmic Solution low doseDrug
Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
DE-127 Ophthalmic Solution medium doseDrug
Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
DE-127 Ophthalmic Solution high doseDrug
High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Placebo Ophthalmic SolutionDrug
Placebo Ophthalmic Solution dosed once daily for 12 months
| Study group | Role | What they receive |
|---|---|---|
| DE-127 Ophthalmic Solution low dose | Experimental | Not described Receives: Drug: DE-127 Ophthalmic Solution low dose |
| DE-127 Ophthalmic Solution medium dose | Experimental | Not described Receives: Drug: DE-127 Ophthalmic Solution medium dose |
| DE-127 Ophthalmic Solution high dose | Experimental | Not described Receives: Drug: DE-127 Ophthalmic Solution high dose |
| Placebo Ophthalmic Solution | Placebo comparator | Not described Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical equivalent
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start27 Oct 2017
- Primary completion12 Sep 2019
- Study completion9 Apr 2020
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329638
- Sponsor's protocol ID
- 012701LT
- Status last verified
- Aug 2020
- First submitted
- 30 Oct 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution Compared With Placebo in Subjects With Mild or Moderate Myopia (APPLE)
- ClinicalTrials.gov ID
- NCT03329638
- Acronym / sponsor ID
- 012701LT
- Conditions
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 6 Nov 2017 (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.
To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia.
To investigate the dose response of DE-127.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DE-127 Ophthalmic Solution low dose | Experimental | Drug: DE-127 Ophthalmic Solution low dose |
| DE-127 Ophthalmic Solution medium dose | Experimental | Drug: DE-127 Ophthalmic Solution medium dose |
| DE-127 Ophthalmic Solution high dose | Experimental | Drug: DE-127 Ophthalmic Solution high dose |
| Placebo Ophthalmic Solution | Placebo comparator | Drug: Placebo Ophthalmic Solution |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes
- Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes
- Distance vision correctable to logMAR 0.2 or better in both eyes
- Normal intraocular pressure of not greater than 21 mmHg in both eyes
- No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
Key exclusion criteria (4 listed)
- Amblyopia or manifest strabismus including intermittent tropia
- Ocular disorders that potentially affect myopia or refractive power
- Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia
- Systemic disorders that potentially affect myopia or refractive power
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 |
|---|---|---|
| DE-127 Ophthalmic Solution low doseLow dose of DE-127 Ophthalmic Solution dosed once daily for 12 months | Drug | DE-127 Ophthalmic Solution low dose |
| DE-127 Ophthalmic Solution medium doseMedium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months | Drug | DE-127 Ophthalmic Solution medium dose |
| DE-127 Ophthalmic Solution high doseHigh dose of DE-127 Ophthalmic Solution dosed once daily for 12 months | Drug | DE-127 Ophthalmic Solution high dose |
| Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution dosed once daily for 12 months | Drug | Placebo Ophthalmic Solution |
Primary outcome
Spherical equivalent
Time frame: Month 12
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.
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 26 Aug 2020.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DE-127 Ophthalmic Solution low dose, DE-127 Ophthalmic Solution medium dose and DE-127 Ophthalmic Solution high dose in people with Myopia, run by Santen Pharmaceutical Co., Ltd. at 1 site in Singapore.
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 4 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 26 Aug 2020. 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 Singapore. 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 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?
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?
Spherical equivalent (time frame: Month 12). 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 26 Aug 2020.