Status:
COMPLETED
A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Conditions:
Myopia
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
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 respo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2020
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03329638
Start Date
October 27 2017
End Date
April 9 2020
Last Update
August 26 2020
Active Locations (1)
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1
Singapore National Eye Centre
Singapore, Singapore