A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or … (NCT03329638) | Clinical Trial Compass
CompletedPhase 2
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
Singapore99 participantsStarted 2017-10-27
Plain-language 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.
Who can participate
Age range6 Years – 11 Years
SexALL
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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