NCT01829230

Brief Summary

This is a continuation study for subjects who were previously fit with test or control lenses; all will stop wearing their study lenses assigned in the previous study and will start to wear an FDA-approved marketed spherical soft contact lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 25, 2014

Completed
Last Updated

June 19, 2018

Status Verified

July 1, 2015

Enrollment Period

1.6 years

First QC Date

April 8, 2013

Results QC Date

September 18, 2014

Last Update Submit

June 18, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Axial Length of the Eye

    Axial length was measured with the IOLMaster at baseline and then every 6 months throughout the course of the study. Five measurements were collected at each visit from the subject's right eye and the average of the 5 measurements was used for the analysis.

    Baseline and every 6 months post-baseline up to 18 months

  • Spherical Equivalent Refractive Error

    Cycloplegic spherical equivalent refraction of the subjects's right eye was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 5 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis.

    Baseline and every 6 months up to 18 months

Study Arms (2)

Test lens C

EXPERIMENTAL

Test lens C from previous study

Device: 1 Day Acuvue Moist

Test lens A

ACTIVE COMPARATOR

Test lens A from previous study

Device: 1 Day Acuvue Moist

Interventions

1 Day Acuvue MoistDEVICE

Lenses will be worn in a daily wear modality

Test lens ATest lens C

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • The subject must be enrolled in the parent protocol for at least one year.
  • The subject's parent or legal guardian must read and sign the STATEMENT OF INFORMED CONSENT and the subject must read and sign the Child's Assent Form and be provided a copy of each form.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

You may not qualify if:

  • Ocular or systemic allergies that may interfere with contact lens wear.
  • Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with contact lens wear.
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV)
  • Diabetes
  • Previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. Rigid contact lens wearers cannot be enrolled in the study.
  • Strabismus.
  • Pupil or lid abnormality or infection in either eye
  • Central corneal scar in either eye
  • Aphakia in either eye
  • Contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear.
  • History of participation in prior clinical trials aimed to control myopia progression, except for the parent trial
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Lawrenson JG, Shah R, Huntjens B, Downie LE, Virgili G, Dhakal R, Verkicharla PK, Li D, Mavi S, Kernohan A, Li T, Walline JJ. Interventions for myopia control in children: a living systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 16;2(2):CD014758. doi: 10.1002/14651858.CD014758.pub2.

    PMID: 36809645DERIVED

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
XU CHENG, PRINCIPAL CLINICAL SCIENTIST
Organization
Vistakon USA
xcheng6@its.jnj.com
1 904 443-1245

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 11, 2013

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 19, 2018

Results First Posted

September 25, 2014

Record last verified: 2015-07

Locations

US(1)