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

• Status: Completed
• Trial end date: 2020-04-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Pharmaceutical Co., Ltd.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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