LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

Myopia Clinical Trial

Official title:

LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735045
• Other study ID #: HF-2010-01
• Status: Completed
• Phase: Phase 3
• First received: June 11, 2012
• Last updated: November 25, 2012
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: Szabocsik and Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Daily Wear
• Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens

Locations

Country	Name	City	State
United States	Douglas P. Benoit, OD, FAAO	Concord	New Hampshire
United States	Randall Sakamoto	Honolulu	Hawaii
United States	Glenda Secor, OD	Huntington Beach	California
United States	Stephen P. Byrnes, OD, FAAO	Londonderry	New Hampshire
United States	Robert Davis, OD	Oak Lawn	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Szabocsik and Associates, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	Snelling Scale	3 months	No
Secondary	Slit Lamp Findings	Grading by the Slit Lamp Classification Scale	3 months	Yes