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A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)

NCT03329638 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2020-08-26

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DRUG

DE-127 Ophthalmic Solution low dose

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

DRUG

DE-127 Ophthalmic Solution medium dose

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

DRUG

DE-127 Ophthalmic Solution high dose

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

DRUG

Placebo Ophthalmic Solution

Placebo Ophthalmic Solution dosed once daily for 12 months

Sponsors & Collaborators

  • Santen Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-27
Primary Completion
2019-09-12
Completion
2020-04-09

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329638 on ClinicalTrials.gov