NCT03312257

Brief Summary

This study will test whether the combined treatment of 0.01% atropine and soft bifocal contact lens wear produces slower myopia progression and axial elongation compared to soft bifocal contact lenses alone in children ages 7 to 11 years old.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 9, 2022

Completed
Last Updated

December 9, 2022

Status Verified

November 1, 2022

Enrollment Period

3.9 years

First QC Date

October 12, 2017

Results QC Date

October 19, 2022

Last Update Submit

November 14, 2022

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

  • Refractive Error Progression

    Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the combination treatment (+2.50 D add soft bifocal lens and 0.01% atropine) group and the historical control group (+2.50 D add soft bifocal lens only) in the BLINK Study.

    3 years

Secondary Outcomes (1)

  • Axial Length Progression

    3 years

Study Arms (1)

Multifocal D +2.50 add & 0.01% atropine

EXPERIMENTAL

The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power; the 0.01% atropine is a low-dose atropine.

Combination Product: Multifocal D +2.50 add & 0.01% atropine

Interventions

Multifocal D +2.50 add & 0.01% atropineCOMBINATION_PRODUCT

Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.

Multifocal D +2.50 add & 0.01% atropine

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 11 years, inclusive, at baseline examination
  • to -5.00 D, inclusive, spherical component, cycloplegic autorefraction
  • ≤1.00 DC, cycloplegic autorefraction
  • ≤ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction
  • logMAR or better best-corrected visual acuity in each eye
  • logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens
  • +2.50 D add lens provides adequate fit with respect to movement and centration
  • Finish at least 71% of 0.01% atropine during the run-in period

You may not qualify if:

  • Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
  • Previous intraocular or corneal surgery
  • Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.)
  • Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear)
  • Previous or current participation in myopia control studies
  • Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases
  • Issues that may interfere with the ability to participate over the next 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Jones JH, Mutti DO, Jones-Jordan LA, Walline JJ. Effect of Combining 0.01% Atropine with Soft Multifocal Contact Lenses on Myopia Progression in Children. Optom Vis Sci. 2022 May 1;99(5):434-442. doi: 10.1097/OPX.0000000000001884. Epub 2022 Feb 25.

    PMID: 35511120DERIVED

  • Huang J, Mutti DO, Jones-Jordan LA, Walline JJ. Bifocal & Atropine in Myopia Study: Baseline Data and Methods. Optom Vis Sci. 2019 May;96(5):335-344. doi: 10.1097/OPX.0000000000001378.

    PMID: 31046016DERIVED

MeSH Terms

Conditions

Refractive Errors

Interventions

Atropine

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
Jeffrey Walline
Organization
Ohio State University
walline.1@osu.edu
614-247-6840

Study Officials

  • Juan Huang, PhD, OD

    The Ohio State Univeristy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 17, 2017

Study Start

July 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

December 9, 2022

Results First Posted

December 9, 2022

Record last verified: 2022-11