Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children

NCT06697522 | Completed Phase 3

• 1 other identifier: Protocol V 7.0
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of atropine sulfate eye drops (0.01%) in treating transient myopia induced by near work tasks (NITM) in pediatric subjects.

Conditions

Myopia

Keywords

Atropine

Outcome Measures

Primary Outcomes (1)

• Change in initial NITM (Nearwork-induced transient myopia) values from baseline to week 12.

  Compare the autorefractor NITM results measured in week 12 of the experimental and control group.

  DAY 1 & Week 12

Secondary Outcomes (5)

• Change from baseline in initial NITM values at week 2 and week 24

  Week 2 and week 24

• Initial NITM values

  Week 2

• Initial NITM values

  Week 12

• Initial NITM values

  Week 24

• The difference between the change in initial NITM values

  Day 1 & Week 12 & Week 24

Study Arms (2)

0.01% Atropine

EXPERIMENTAL

Atropine Sulfate Eye Drops, conc. 0.01%

Drug: Atropine Sulfate

Blank Solvent

PLACEBO COMPARATOR

Blank solvent placebo

Drug: Placebo

Interventions

Atropine Sulfate DRUG

low concentration atropine (0.01%)

Also known as: Investigational product

0.01% Atropine

Placebo DRUG

Blank comparator

Also known as: Blank Solvent

Blank Solvent

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• For subjects of age between 6 to 8, their parents or legal guardians must provide written informed consent; For 8 year old subjects and above, both the subjects and their legal guardians need to sign the informed consent form.
• They must be able to comply with the research requirements, attend all study visits, and be accompanied by their parents/legal guardians.
• The age range during the screening period (from Day -14 to Day 0) is 6-15 years, with no gender restrictions.
• The optometry results during the screening period should show: a) Myopia between -0.50DS and -4.00DS. b) Astigmatism ≤1.50DC, and less than half of the spherical lens power. c) The initial NITM value (equivalent sphere) for either eye should be ≤-0.40D.
• The difference in refractive error between both eyes during the screening period should be ≤1.00D in equivalent spherical lens power.
• The best corrected visual acuity (BCVA) for both eyes during the screening period should be ≥0.8 on the standard logarithmic visual acuity chart.
• They must be able and willing to avoid using all prohibited medications during the washout period between screening and randomization, as well as during the study period, with no significant risk to the subjects.

You may not qualify if:

• Known contraindications or allergies to atropine sulfate, the study drug, or its components.
• Clinically significant abnormal findings on slit-lamp microscopy examination (e.g., cataract) that may affect the measurement of best-corrected visual acuity in either eye at the time of screening, or known clinically significant findings from a previous slit-lamp microscopy examination in either eye.
• Clinically significant abnormal findings on direct ophthalmoscopy at the time of screening in either eye, or known previous clinically significant retinal findings in either eye.
• Evidence of any ocular motility disorder or restriction of extraocular muscle movement (e.g., nystagmus).
• Presence of infectious eye diseases (such as bacterial, viral, or fungal infections).
• Active ocular inflammation in either eye or a history of chronic or recurrent ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis).
• History of ocular herpes virus infection, iritis, scleritis, or uveitis, regardless of whether it is active at the time of screening.
• Abnormal pupillary light reflex and/or amblyopia at the time of screening.
• Intraocular pressure (IOP) in either eye \<9mmHg or \>21mmHg at the time of screening, or a difference in IOP between both eyes ≥5mmHg, or a previous diagnosis of ocular hypertension or glaucoma, or currently receiving any type of topical IOP-lowering (glaucoma) medication.
• Received surgical intervention (ocular or systemic) within 6 months prior to the screening period, or planning to receive surgical intervention during the study period.
• Use of any prohibited medication or treatment (ocular or periocular topical medication, systemic medication, injectable medication, and use of any lenses that can slow the progression of myopia) during the specified period before Visit 1. These medications or treatments are also prohibited during the study period. The shortest reasonable washout period for prohibited medications or treatments is:
• Any prescription or over-the-counter ophthalmic product (3 days); artificial tears are allowed, but not within 2 hours after the administration of the study drug.
• Monoamine oxidase inhibitors (7 days).
• Atropine, pirenzepine, or other anticholinergic drugs (60 days).
• Any medication affecting the pupil or accommodation (60 days).

Sponsors & Collaborators

• Ocumension Therapeutics (Suzhou) Co., Ltd: lead
• Beijing Children's Hospital: collaborator

Study Sites (1)

Beijing Children's Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Xiaoling Wang

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

• Li Li

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: June 25, 2023
• Primary Completion: October 6, 2023
• Study Completion: March 26, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)