LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Szabocsik and Associates, Inc.
ClinicalTrials.gov Identifier:
NCT01735045
First received: June 11, 2012
Last updated: November 25, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Myopia
Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

Resource links provided by NLM:


Further study details as provided by Szabocsik and Associates, Inc.:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Snelling Scale


Secondary Outcome Measures:
  • Slit Lamp Findings [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Grading by the Slit Lamp Classification Scale


Enrollment: 76
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735045

Locations
United States, California
Glenda Secor, OD
Huntington Beach, California, United States, 92647
United States, Hawaii
Randall Sakamoto
Honolulu, Hawaii, United States, 96814
United States, Illinois
Robert Davis, OD
Oak Lawn, Illinois, United States, 60453
United States, New Hampshire
Douglas P. Benoit, OD, FAAO
Concord, New Hampshire, United States, 03301
Stephen P. Byrnes, OD, FAAO
Londonderry, New Hampshire, United States, 03053
Sponsors and Collaborators
Szabocsik and Associates, Inc.
Investigators
Study Director: John M Szabocsik, PhD
  More Information

No publications provided

Responsible Party: Szabocsik and Associates, Inc.
ClinicalTrials.gov Identifier: NCT01735045     History of Changes
Other Study ID Numbers: HF-2010-01
Study First Received: June 11, 2012
Last Updated: November 25, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 30, 2014