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Clinical Trials/NCT01309893
NCT01309893
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
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ConditionsMyopia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myopia
Sponsor
Bausch & Lomb Incorporated
Enrollment
66
Locations
1
Primary Endpoint
Distance High Contrast logMAR Visual Acuity at 1 Week
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
February 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 myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion Criteria

  • •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

Distance High Contrast logMAR Visual Acuity at 1 Week

Time Frame: Baseline & 1 week

Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week

Secondary Outcomes

  • Overall Comfort(1 week)
  • Slit Lamp Findings ≥ Grade 2(1 week)

Study Sites (1)

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