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OpenTrials
Completed

NCT Number: NCT01024751

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

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.

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Key information

Conditions

Ocular Discomfort

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bausch & Lomb Multi-Purpose Solution

Device

Lens care product for disinfecting lenses on a daily basis.

Ciba's Multi-Purpose Solution

Device

Lens care product for disinfecting lenses on a daily basis.

Primary outcomes

  1. Comfort-related Symptoms/Complaints

    Time frame: At dispensing visit and each follow-up visit at week 2 and week 4.

    Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.

Secondary outcomes

  1. Slit Lamp Findings

    Time frame: Over all visits for 1 month

    Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2009
Registry last updated
Aug 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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