LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens; Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Glenda Secor, OD
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Randall Sakamoto
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Robert Davis, OD
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • Douglas P. Benoit, OD, FAAO
    • Londonderry, New Hampshire, United States, 03053
      • Stephen P. Byrnes, OD, FAAO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group myopia control; 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; Daily Wear
Active Comparator: Myopia Control; Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control	Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Snelling Scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Findings	Grading by the Slit Lamp Classification Scale	3 months

Collaborators and Investigators

• Sponsor: Szabocsik and Associates, Inc.
• Investigators: Study Director: John M Szabocsik, PhD

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: November 25, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): November 28, 2012
• Last Update Submitted That Met QC Criteria: November 25, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: HF-2010-01