A Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution in Subjects With Mild or Moderate Myopia (APPLE)
NCT ID: NCT03329638
Last Updated: 2020-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
99 participants
INTERVENTIONAL
2017-10-27
2020-04-09
Brief Summary
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To investigate the dose response of DE-127.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DE-127 Ophthalmic Solution low dose
DE-127 Ophthalmic Solution low dose
Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
DE-127 Ophthalmic Solution medium dose
DE-127 Ophthalmic Solution medium dose
Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
DE-127 Ophthalmic Solution high dose
DE-127 Ophthalmic Solution high dose
High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution dosed once daily for 12 months
Interventions
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DE-127 Ophthalmic Solution low dose
Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
DE-127 Ophthalmic Solution medium dose
Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
DE-127 Ophthalmic Solution high dose
High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
Placebo Ophthalmic Solution
Placebo Ophthalmic Solution dosed once daily for 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
11 Years
ALL
No
Sponsors
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Santen Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Singapore National Eye Centre
Singapore, , Singapore
Countries
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Other Identifiers
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012701LT
Identifier Type: -
Identifier Source: org_study_id
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