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

Phase 2

Completed

• Conditions: Myopia
• Interventions: Drug: DE-127 Ophthalmic Solution low dose; Drug: Placebo Ophthalmic Solution; Drug: DE-127 Ophthalmic Solution medium dose; Drug: DE-127 Ophthalmic Solution high dose

• Registration Number: NCT03329638
• Lead Sponsor: Santen Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-27
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Primary Completion: 2019-09-12
• Study Completion: 2020-04-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DE-127 Ophthalmic Solution low dose	DE-127 Ophthalmic Solution low dose	-
Placebo Ophthalmic Solution	Placebo Ophthalmic Solution	-
DE-127 Ophthalmic Solution medium dose	DE-127 Ophthalmic Solution medium dose	-
DE-127 Ophthalmic Solution high dose	DE-127 Ophthalmic Solution high dose	-

Primary Outcome Measures

Name	Time	Method
Spherical equivalent	Month 12	Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.

Trial Locations

Locations (1)

Singapore National Eye Centre; 🇸🇬 Singapore, Singapore