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Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression

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ClinicalTrials.gov Identifier: NCT03942419
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Eyenovia Inc.

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
Myopia progression [ Time Frame: 36 Months ]
The proportion of primary study eyes showing less than 0.50 D (spherical equivalent) myopia progression compared to baseline measured using cycloplegic autorefraction.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03942419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 7, 2019)
  • Visual acuity [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Visual acuity measured using ETDRS (or HOTV for younger children) protocol
  • Intraocular pressure [ Time Frame: 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Intraocular pressure measured using tonometry
  • Eyelid erythema [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Eyelid erythema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)
  • Eyelid edema [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Eyelid edema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)
  • Conjunctival hyperemia [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Conjunctival hyperemia evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)
  • Conjunctival edema [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Conjunctival edema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)
  • Sclera appearance [ Time Frame: 1, 6, 12, 8, 24, 30, 36, 42, 48 months after treatment initiation ]
    Scleral appearance evaluated using slit lamp biomicroscopy; categories are "normal" and "abnormal"
  • Corneal edema [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Corneal edema evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)
  • Corneal staining [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Corneal staining evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (normal) to 3 (severe)
  • Anterior chamber cells [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Anterior chamber cells evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (none) to 4 (hypopyon)
  • Anterior chamber flare [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Anterior chamber flare evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (none) to 3 (milky aqueous)
  • Iris appearance [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Iris appearance evaluated using slit lamp biomicroscopy; categories are "normal" and "abnormal"
  • Lens opacity [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Lens opacity evaluated using slit lamp biomicroscopy and a numeric grading scale ranging from 0 (none) to 3 (dense)
  • Anterior vitreous appearance [ Time Frame: 1, 6, 12, 18, 24, 30, 36, 42, 48 months after treatment initiation ]
    Anterior vitreous appearance evaluated using slit lamp biomicroscopy; categories are "normal" and "abnormal"
  • Fundus findings [ Time Frame: 12, 24, 36, 48 months after treatment initiation ]
    Dilated fundus findings evaluated using an ophthalmoscope; categories are "normal" and "abnormal"
  • Adverse events [ Time Frame: Baseline, 1, 6, 12, 18, 24, 30, 36, 40, 48 months after treatment initiation ]
    Untoward medical occurrences
 
Descriptive Information
Brief Title  ICMJE Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
Official Title  ICMJE A Multicenter, Double-Masked, Randomized, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of Atropine 0.1% and 0.01% Ophthalmic Solutions Administered With a Microdose Dispenser for the Reduction of Pediatric Myopia Progression (The CHAPERONE Study)
Brief Summary This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.
Detailed Description

Subjects will be evaluated for eligibility during an initial Screening Visit and enrolled after signing the study-specific informed consent form(s). Eligible subjects must complete a run-in period where they use the microdose dispenser to administer study drug "vehicle" solution daily in both eyes. After run-in, subjects return for a Baseline Visit and additional study eligibility assessments. Subjects who continue to be eligible will be equally randomized to one of the following treatment groups:

  • Microdose atropine 0.1% ophthalmic solution
  • Microdose atropine 0.01% ophthalmic solution
  • Microdose placebo ophthalmic solution

Randomization will be stratified by iris color (e.g., dark and light) and study site. Study enrollment will be limited to a maximum of 50% of subjects who self-identify as East Asian ethnicity. Subjects will use their assigned study medication daily in both eyes and return for efficacy and safety assessments at 1, 6, 12, 18, 24, 30, and 36 months.

At the Month 36 Visit, subjects in the 2 atropine dose arms will be re-randomized to either placebo or 1 of the 2 doses of atropine ophthalmic solution, while subjects originally assigned to placebo will be re-randomized to one of the 2 atropine ophthalmic solution arms. After re-randomization, all subjects will be followed for an additional year with efficacy and safety examinations at Months 42 and 48.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a multi-center, double masked, randomized, placebo-controlled study evaluating the efficacy of microdosed atropine 0.01%, atropine 0.1% and placebo ophthalmic solutions. Subjects will administer their assigned medication daily in both eyes for 36 months, then be re-randomized to the same or an alternative treatment arm and followed for an additional 12 months.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
There will be no differences in the presentation of study drug administered. All study personnel conducting ophthalmic assessments will be masked to treatment assignment.
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE
  • Drug: Atropine 0.1% Ophthalmic Solution
    Atropine 0.1% ophthalmic solution administered with a microdose dispenser
  • Drug: Atropine 0.01% Ophthalmic Solution
    Atropine 0.01% ophthalmic solution administered with a microdose dispenser
  • Drug: Placebo Ophthalmic Solution
    Placebo ophthalmic solution administered with a microdose dispenser
Study Arms  ICMJE
  • Experimental: Atropine 0.1% Ophthalmic Solution
    Atropine 0.1% ophthalmic solution administered daily in both eyes using a microdose dispenser
    Intervention: Drug: Atropine 0.1% Ophthalmic Solution
  • Experimental: Atropine 0.01% Ophthalmic Solution
    Atropine 0.01% ophthalmic solution administered daily in both eyes using a microdose dispenser
    Intervention: Drug: Atropine 0.01% Ophthalmic Solution
  • Placebo Comparator: Placebo Ophthalmic Solution
    Placebo ophthalmic solution administered daily in both eyes using a microdose dispenser
    Intervention: Drug: Placebo Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2024
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Refractive error by cycloplegic autorefraction: myopia -1.00 D to -6.00 D in both eyes; astigmatism ≤ 1.50 D in both eyes; anisometropia < 1.50 D.
  • Best-corrected distance visual acuity in current correction of 0.2 logMAR or better with interocular difference ≤ 0.1 logMAR.
  • Refractive correction for each eye meets the following criteria: myopia within ± 0.50 D of the cycloplegic refraction at the Screening Visit; cylinder power within ± 0.50 D of the cycloplegic refraction at the Screening Visit; when cylinder power is < 1.00 D, axis within ± 15 degrees of the cycloplegic refraction; when cylinder power is ≥ 1.00 D, axis within ± 5 degrees of the cycloplegic refraction.

Exclusion Criteria:

  • Current or previous myopia treatment with non-study atropine, pirenzepine or other topical anti-muscarinic agent.
  • Current use of bifocals, progressive-addition lenses, or multifocal soft contact lenses.
  • Use of rigid gas permeable lenses, including orthokeratology lenses within 90 days of Screening.
  • Known atropine allergy.
  • Abnormality of the cornea, lens, central retina, iris or ciliary body.
  • Current or prior history of manifest strabismus, amblyopia, or nystagmus.
  • Prior eyelid, strabismus, intraocular, or refractive surgery.
  • Intraocular pressure > 26 mmHg.
  • History of premature birth by parent's report.
  • Inability to perform protocol-prescribed testing due to preexisting neurological diagnoses, genetic syndrome, or other issues.
  • Medical conditions predisposing patient to degenerative myopia, abnormal ocular refractive anatomy, and/or any history of intraocular surgery.
  • Any systemic disease or condition that may affect visual function or development such as diabetes mellitus.
  • Any ocular inflammation or external ocular inflammation within 30 days of Screening.
  • History of punctal occlusion.
  • Heterochromia.
  • Lid squeezers.
  • Participation in any study of an investigational, interventional product within 30 days prior to Screening Visit.
  • Immediate family member of study staff designed to perform study evaluations or procedures.
  • Pregnancy, or if sexually active, unwillingness to use an acceptable form of contraception during the study.
  • Presence of a severe/serious ocular condition or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Greg M Bennett, MSEd 650-504-2005 gbennett@eyenoviabio.com
Contact: Ginger Clasby, MS 714-269-8838 gclasby@eyenoviabio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03942419
Other Study ID Numbers  ICMJE EYN-MYO-AT-31
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eyenovia Inc.
Study Sponsor  ICMJE Eyenovia Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tsontcho Ianchulev, MD, MPH Eyenovia Inc.
PRS Account Eyenovia Inc.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP