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Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

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Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: Redesigned Purevision Contact Lens
Device: PureVision Contact Lens

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

376 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

376 participants in 2 patient groups

Redesigned Purevision Contact Lens
Experimental group
Description:
Redesigned Bausch \& Lomb PureVision contact lens
Treatment:
Device: Redesigned Purevision Contact Lens
PureVision Contact Lens
Active Comparator group
Description:
Bausch \& Lomb PureVision contact lens
Treatment:
Device: PureVision Contact Lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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