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A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

Bausch + Lomb logo

Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: PureVision Toric Lens
Device: Investigational Toric Lens

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.

Enrollment

302 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Subjects must be myopic and require lens correction
  • Subjects must be habitual wearers of toric soft contact lenses.

Exclusion criteria

  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • 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 who are using any ocular medication.
  • Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects who are allergic to any component in the study care products.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

302 participants in 2 patient groups

Investigational Toric Lens
Experimental group
Description:
Bausch + Lomb investigational toric contact lenses
Treatment:
Device: Investigational Toric Lens
PureVision Toric Lens
Active Comparator group
Description:
Currently marketed Bausch + Lomb PureVision toric contact lenses
Treatment:
Device: PureVision Toric Lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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