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

Santen

Status and phase: Completed; Phase 2

Conditions: Myopia

Treatments: Drug: DE-127 Ophthalmic Solution high dose; Drug: DE-127 Ophthalmic Solution low dose; Drug: DE-127 Ophthalmic Solution medium dose; Drug: Placebo Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT03329638

012701LT

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 4 patient groups, including a placebo group

DE-127 Ophthalmic Solution low dose

Experimental group

Treatment:

Drug: DE-127 Ophthalmic Solution low dose

DE-127 Ophthalmic Solution medium dose

Experimental group

Treatment:

Drug: DE-127 Ophthalmic Solution medium dose

DE-127 Ophthalmic Solution high dose

Experimental group

Treatment:

Drug: DE-127 Ophthalmic Solution high dose

Placebo Ophthalmic Solution

Placebo Comparator group

Treatment:

Drug: Placebo Ophthalmic Solution