Back to resultsA Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
Primary Purpose
Myopia
Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
DE-127 Ophthalmic Solution low dose
DE-127 Ophthalmic Solution medium dose
DE-127 Ophthalmic Solution high dose
Placebo Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Singapore National Eye Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
DE-127 Ophthalmic Solution low dose
DE-127 Ophthalmic Solution medium dose
DE-127 Ophthalmic Solution high dose
Placebo Ophthalmic Solution
Arm Description
Outcomes
Primary Outcome Measures
Spherical equivalent
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.
Secondary Outcome Measures
Full Information
NCT ID
NCT03329638
First Posted
October 30, 2017
Last Updated
August 25, 2020
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03329638
Brief Title
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 27, 2017 (Actual)
Primary Completion Date
September 12, 2019 (Actual)
Study Completion Date
April 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DE-127 Ophthalmic Solution low dose
Arm Type
Experimental
Arm Title
DE-127 Ophthalmic Solution medium dose
Arm Type
Experimental
Arm Title
DE-127 Ophthalmic Solution high dose
Arm Type
Experimental
Arm Title
Placebo Ophthalmic Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
DE-127 Ophthalmic Solution low dose
Intervention Description
Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
DE-127 Ophthalmic Solution medium dose
Intervention Description
Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
DE-127 Ophthalmic Solution high dose
Intervention Description
High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Solution
Intervention Description
Placebo Ophthalmic Solution dosed once daily for 12 months
Primary Outcome Measure Information:
Title
Spherical equivalent
Description
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.
Time Frame
Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
We'll reach out to this number within 24 hrs