NCT03329638

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Santen Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2017-10-27
• Primary completion: 2019-09-12
• Completion: 2020-04-09
• First posted: 2017-11-06
• Last updated: 2020-08-26

Locations

1 site across 1 country: Singapore