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

Sponsor

Santen Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03329638

Collaborator

(none)

Enrollment

Location

Arms

29.4

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	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	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Oct 27, 2017

Actual Primary Completion Date :

Sep 12, 2019

Actual Study Completion Date :

Apr 9, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Spherical equivalent [Month 12]
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore National Eye Centre	Singapore		Singapore

Sponsors and Collaborators

Santen Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Santen Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03329638

Other Study ID Numbers:

012701LT

First Posted:

Nov 6, 2017

Last Update Posted:

Aug 26, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myopia

Pharmaceutical Solutions

Ophthalmic Solutions

Study Results

No Results Posted as of Aug 26, 2020