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Clinical Trials/NCT01309880
NCT01309880
Completed
Not Applicable

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

Bausch & Lomb Incorporated1 site in 1 country66 target enrollmentDecember 2010
ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Bausch & Lomb Incorporated
Enrollment
66
Locations
1
Primary Endpoint
Visual Acuity
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
January 2011
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria

  • Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • An active ocular disease, any corneal infiltrative response or are using any ocular medications.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Allergic to any component in the study care products.

Outcomes

Primary Outcomes

Visual Acuity

Time Frame: Dispensing & 1-week follow up

Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.

Secondary Outcomes

  • Slit Lamp Findings(1 week)
  • Comfort(1 Weeks)

Study Sites (1)

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