LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Visual Acuity [3 months]
Snelling Scale
Secondary Outcome Measures
- Slit Lamp Findings [3 months]
Grading by the Slit Lamp Classification Scale
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Glenda Secor, OD | Huntington Beach | California | United States | 92647 |
| 2 | Randall Sakamoto | Honolulu | Hawaii | United States | 96814 |
| 3 | Robert Davis, OD | Oak Lawn | Illinois | United States | 60453 |
| 4 | Douglas P. Benoit, OD, FAAO | Concord | New Hampshire | United States | 03301 |
| 5 | 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,
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HF-2010-01