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Clinical Trials/NCT01118338
NCT01118338CompletedNot Applicable

A Study to Evaluate the Product Performance of Two Different Designs of Bausch & Lomb PureVision® Contact Lenses

Bausch & Lomb Incorporated2 sites in 1 country376 target enrollmentStarted: May 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
376
Locations
2
Primary Endpoint
Symptoms and Complaints
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subjects must have clear central corneas and be free of any anterior segment disorders.
  • •Subjects must be adapted wearers of one of the listed contact lenses
  • •Subjects must be myopic
  • •Subjects must use a lens care system on a regular basis.

Exclusion Criteria

  • •Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
  • •Subjects with any systemic disease affecting ocular health.
  • •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • •Subjects with an active ocular disease or are using any ocular medication.
  • •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • •Subjects who have had any corneal surgery (eg, refractive surgery).
  • •Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Outcomes

Primary Outcomes

Symptoms and Complaints

Time Frame: 1 month

Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.

Secondary Outcomes

  • Visual Acuity(1 month)
  • Percentage of Eyes With > Grade 2 Slit Lamp Findings(1 month)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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