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A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

Not Applicable
Completed
Conditions
Myopia
Interventions
Device: Bausch & Lomb Test lens
Device: Ciba Vision soft contact lens
Registration Number
NCT01412983
Lead Sponsor
Bausch & Lomb Incorporated
Brief Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
  • Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
  • Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.
Exclusion Criteria
  • An active ocular disease, any corneal infiltrative response or are using any ocular medications.
  • Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
  • Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any scar or neovascularization within the central 4mm of the cornea.
  • Have had any corneal surgery.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Currently wear monovision, multifocal, or toric contact lenses.
  • Allergic to any component in the study care products.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Bausch & Lomb Test LensBausch & Lomb Test lensBausch + Lomb investigational soft contact lens
Ciba Vision soft contact lensCiba Vision soft contact lensCiba Vision Air Optix Aqua soft contact lens
Primary Outcome Measures
NameTimeMethod
Visual AcuityOne week

The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.

Secondary Outcome Measures
NameTimeMethod
Overall ComfortOne week

The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated

🇺🇸

Rochester, New York, United States

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