A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
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)
1 other identifier
interventional
99
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 27, 2017
CompletedFirst Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2020
CompletedAugust 26, 2020
August 1, 2020
1.9 years
October 30, 2017
August 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Spherical equivalent
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.
Month 12
Study Arms (4)
DE-127 Ophthalmic Solution low dose
EXPERIMENTALDE-127 Ophthalmic Solution medium dose
EXPERIMENTALDE-127 Ophthalmic Solution high dose
EXPERIMENTALPlacebo Ophthalmic Solution
PLACEBO COMPARATORInterventions
Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Placebo Ophthalmic Solution dosed once daily for 12 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Singapore National Eye Centre
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 6, 2017
Study Start
October 27, 2017
Primary Completion
September 12, 2019
Study Completion
April 9, 2020
Last Updated
August 26, 2020
Record last verified: 2020-08