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Safety and Efficacy of a Contact Lens for Daily Disposable Use

Bausch + Lomb logo

Bausch + Lomb

Status

Completed

Conditions

Myopia

Treatments

Device: SofLens daily disposable contact lens
Device: Test, daily disposable contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01365039
690 (Other Identifier)

Details and patient eligibility

About

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Enrollment

173 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
  • Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
  • Subjects must be free of any anterior segment disorders.
  • Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

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 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 are allergic to any component in the study care products.

Trial design

173 participants in 2 patient groups

Test lens
Experimental group
Description:
Test contact lens will be worn on a daily disposable wear basis.
Treatment:
Device: Test, daily disposable contact lens
SofLens lens
Active Comparator group
Description:
The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.
Treatment:
Device: SofLens daily disposable contact lens

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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