LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
This study has been completed.
Sponsor:
Szabocsik and Associates, Inc.
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
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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:
- 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
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 |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on June 17, 2013