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

Myopia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03329638
• Other study ID #: 012701LT
• Status: Completed
• Phase: Phase 2
• Start date: October 27, 2017
• Est. completion date: April 9, 2020

Study information

• Verified date: August 2020
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 9, 2020
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• DE-127 Ophthalmic Solution low dose
Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
• DE-127 Ophthalmic Solution medium dose
Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
• DE-127 Ophthalmic Solution high dose
High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
• Placebo Ophthalmic Solution
Placebo Ophthalmic Solution dosed once daily for 12 months

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

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