LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
NCT ID: NCT01735045
Last Updated: 2012-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
76 participants
INTERVENTIONAL
2010-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test Group myopia control
Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control
Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Daily Wear
Myopia Control
Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control
Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
Interventions
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Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Daily Wear
Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Szabocsik and Associates, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John M Szabocsik, PhD
Role: STUDY_DIRECTOR
Locations
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Glenda Secor, OD
Huntington Beach, California, United States
Randall Sakamoto
Honolulu, Hawaii, United States
Robert Davis, OD
Oak Lawn, Illinois, United States
Douglas P. Benoit, OD, FAAO
Concord, New Hampshire, United States
Stephen P. Byrnes, OD, FAAO
Londonderry, New Hampshire, United States
Countries
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Other Identifiers
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HF-2010-01
Identifier Type: -
Identifier Source: org_study_id