LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

Szabocsik and Associates

Status and phase: Completed; Phase 3

Conditions: Myopia

Treatments: Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens; Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01735045

HF-2010-01

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

  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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Test Group myopia control

Experimental group

Description:

Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control

Treatment:

Device: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens

Myopia Control

Active Comparator group

Description:

Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control

Treatment:

Device: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens