LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

Completed · Phase 3

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT01735045

Run by

Szabocsik and Associates, Inc.

People needed

76

Starts

2010-05-01

Expected to finish

2012-01-01

Last updated by the study team

2012-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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