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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03329638

Enrollment

Registered

2017-11-06

Start date

2017-10-27

Completion date

2020-04-09

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DRUGDE-127 Ophthalmic Solution low dose

Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months

DRUGDE-127 Ophthalmic Solution medium dose

Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months

DRUGDE-127 Ophthalmic Solution high dose

High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months

DRUGPlacebo Ophthalmic Solution

Placebo Ophthalmic Solution dosed once daily for 12 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Years to 11 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Spherical equivalent	Month 12	Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026