NCT00762970

Brief Summary

This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

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

April 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

July 29, 2015

Completed
Last Updated

June 19, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

September 26, 2008

Results QC Date

July 1, 2015

Last Update Submit

June 18, 2018

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Spherical Equivalent Refraction

    Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia.

    Baseline and every 6 months post-baseline for 2 years

  • Axial Length (Axial Elongation)

    Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up.

    Baseline and every 6 months post-baseline for 2 years

Study Arms (3)

Test Lens 1

EXPERIMENTAL

Investigational soft contact lenses worn daily.

Device: Test Lens 1

Test Lens 2

EXPERIMENTAL

Investigational soft contact lenses worn daily.

Device: Test Lens 2

Control lens

ACTIVE COMPARATOR

Spectacle lenses worn daily.

Device: Control Lens

Interventions

Test Lens 1DEVICE

Investigational soft contact lens with asperic optical design to control myopia progression.

Test Lens 1
Test Lens 2DEVICE

Investigational soft contact lens with asperic optical design to control myopia progression.

Test Lens 2
Control LensDEVICE

Spectacle Lenses.

Control lens

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Myopic subjects between 8 and 12 years of age.
  • The subject best sphere contact lens correction must lie between -0.75D (best of the two eyes) and -5.00D (worst of the two eyes)
  • Astigmatism must be less than or equal to 1.00D
  • D or less difference in spherical equivalent between the two eyes
  • The subject must have a best-corrected visual acuity of 0.8+2 (20/25+2) and spherical equivalent refraction visual acuity of 0.820/25) or better in both eyes
  • The subject must have at least 8D of accommodation
  • The subject and subject's parent or legal guardian must read and sign the STAEMENT OF INFORMED CONSENT
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

You may not qualify if:

  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Systemic disease or autoimmune disease or use of medication (e.g. antihistamine), which may interfere with 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
  • Anisometropia of greater than 1.00D
  • Astigmatism of greater than 1.00D in either eye
  • Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  • Pervious refractive surgery, rigi contact lens wear, orthokeratology, keratconus or other corneal irregularity in either eye.
  • Strabismus in either eye
  • Pupil orr lid abnormality or infection in either eye
  • Central corneal scar in either eye
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Tianjin Eye Hospital

Tianjin, 300020, China

Location

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

Study Officials

  • Xu Cheng, MD, PhD

    Principal Clinical Scientist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

April 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 19, 2018

Results First Posted

July 29, 2015

Record last verified: 2018-04

Locations

CN(1)