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LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

Primary Purpose

Myopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
Sponsored by
Szabocsik and Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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:

    1. No evidence of lid infection.
    2. No structural lid abnormality.
    3. No conjunctival abnormality or infection.
    4. A cornea which is clear with no edema, staining, vascularization or abnormal opacities, all as observed by slit lamp examination.
    5. No iritis.
    6. No other active ocular disease that would contraindicate use of the investigational lens.
    7. 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.

Exclusion Criteria

  • 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

Sites / Locations

  • Glenda Secor, OD
  • Randall Sakamoto
  • Robert Davis, OD
  • Douglas P. Benoit, OD, FAAO
  • Stephen P. Byrnes, OD, FAAO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group myopia control

Myopia Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual Acuity
Snelling Scale

Secondary Outcome Measures

Slit Lamp Findings
Grading by the Slit Lamp Classification Scale

Full Information

First Posted
June 11, 2012
Last Updated
November 25, 2012
Sponsor
Szabocsik and Associates, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01735045
Brief Title
LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
Official Title
LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Szabocsik and Associates, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group myopia control
Arm Type
Experimental
Arm Description
Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control
Arm Title
Myopia Control
Arm Type
Active Comparator
Arm Description
Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control
Intervention Type
Device
Intervention Name(s)
Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Intervention Description
Daily Wear
Intervention Type
Device
Intervention Name(s)
Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Snelling Scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Slit Lamp Findings
Description
Grading by the Slit Lamp Classification Scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Szabocsik, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Glenda Secor, OD
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Randall Sakamoto
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Robert Davis, OD
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Douglas P. Benoit, OD, FAAO
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Stephen P. Byrnes, OD, FAAO
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States

12. IPD Sharing Statement

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LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

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