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)

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 Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Drug: DE-127 Ophthalmic Solution low dose; Drug: DE-127 Ophthalmic Solution medium dose; Drug: DE-127 Ophthalmic Solution high dose; Drug: Placebo Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DE-127 Ophthalmic Solution low dose	Drug: DE-127 Ophthalmic Solution low dose; Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Experimental: DE-127 Ophthalmic Solution medium dose	Drug: DE-127 Ophthalmic Solution medium dose; Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Experimental: DE-127 Ophthalmic Solution high dose	Drug: DE-127 Ophthalmic Solution high dose; High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Placebo Comparator: Placebo Ophthalmic Solution	Drug: Placebo Ophthalmic Solution; Placebo Ophthalmic Solution dosed once daily for 12 months

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Santen Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): April 9, 2020

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 012701LT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No