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A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

Bausch + Lomb logo

Bausch + Lomb

Status

Completed

Conditions

Ocular Discomfort

Treatments

Device: Ciba's Multi-Purpose Solution
Device: Bausch & Lomb Multi-Purpose Solution

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.

Enrollment

312 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
  • Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
  • Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Participants must agree to wear study lenses on a daily wear basis.
  • Participants must be able and willing to comply with all treatment and follow-up/study procedures.

Exclusion criteria

  • Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
  • Participants with any systemic disease affecting ocular health.
  • Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Participants who have had any corneal surgery (eg, refractive surgery).
  • Participants who are allergic to any component in the study care products.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

312 participants in 2 patient groups

Bausch & Lomb Multi-Purpose Solution
Experimental group
Description:
Multi-Purpose Solution to be used for disinfecting contact lenses.
Treatment:
Device: Bausch & Lomb Multi-Purpose Solution
Ciba's Multi-Purpose Solution
Active Comparator group
Description:
Multi-Purpose Solution to be used for disinfecting contact lenses.
Treatment:
Device: Ciba's Multi-Purpose Solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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