NCT01735045

Brief Summary

This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2010

Geographic Reach
1 country

5 active sites

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

May 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
Last Updated

November 28, 2012

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

June 11, 2012

Last Update Submit

November 25, 2012

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Snelling Scale

    3 months

Secondary Outcomes (1)

  • Slit Lamp Findings

    3 months

Study Arms (2)

Test Group myopia control

EXPERIMENTAL

Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control

Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens

Myopia Control

ACTIVE COMPARATOR

Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control

Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens

Interventions

Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact LensDEVICE

Daily Wear

Test Group myopia control
Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact LensDEVICE
Myopia Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have been advised that the contact lenses they will be wearing for the next 3 months are being used for investigational purposes and that their informed consent will be needed and documented prior to the start of the study.
  • Visual acuity must be correctable to 20/30, with spherical lenses ranging in power from -1.00 to -5.00D, astigmatism≤1.50D.
  • Have been successfully wearing soft (hydrophilic) contact lenses for at least one month prior to entering the study. (Success means both subject and practitioner are satisfied with visual acuity, comfort, and ocular physiology).
  • Have non-diseased eyes which are normal or which have no preexisting ocular condition which would interfere with the patient's ability to adapt to the new pair of LSH Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one having all the following characteristics:
  • No evidence of lid infection.
  • No structural lid abnormality.
  • No conjunctival abnormality or infection.
  • A cornea which is clear with no edema, staining, vascularization or abnormal opacities, all as observed by slit lamp examination.
  • No iritis.
  • No other active ocular disease that would contraindicate use of the investigational lens.
  • No GPC (giant papillary conjunctivitis, tarsal abnormality) Grade 2 or greater
  • Use no ocular medication.
  • Have no known sensitivity to solutions currently used for contact lens care.
  • Have binocular correction with contact lenses.

You may not qualify if:

  • Astigmatism \>1.50D
  • No monocular or monovision fits may be included.
  • Pregnant and lactating women are excluded from the study
  • Minors (under age 18) are excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Glenda Secor, OD

Huntington Beach, California, 92647, United States

Location

Randall Sakamoto

Honolulu, Hawaii, 96814, United States

Location

Robert Davis, OD

Oak Lawn, Illinois, 60453, United States

Location

Douglas P. Benoit, OD, FAAO

Concord, New Hampshire, 03301, United States

Location

Stephen P. Byrnes, OD, FAAO

Londonderry, New Hampshire, 03053, United States

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and Supplies

Study Officials

  • John M Szabocsik, PhD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

November 28, 2012

Study Start

May 1, 2010

Primary Completion

December 1, 2011

Study Completion

January 1, 2012

Last Updated

November 28, 2012

Record last verified: 2012-11

Locations

US(5)