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OpenTrials
Completed

NCT Number: NCT01735045

LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Glenda Secor, OD, Huntington Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Daily Wear

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

Device

Primary outcomes

  1. Visual Acuity

    Time frame: 3 months

    Snelling Scale

Secondary outcomes

  1. Slit Lamp Findings

    Time frame: 3 months

    Grading by the Slit Lamp Classification Scale

Sponsors and collaborators

Lead sponsor

Szabocsik and Associates, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Nov 28, 2012
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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