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OpenTrials
Completed

NCT Number: NCT00710879

Evaluation of a Multi-Purpose Solution

This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

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Key information

Conditions

Contact Lens Solutions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Nicholas Marsico

Torrance, California, 90505, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.
  • Must be able and willing to comply with all treatment and follow-up study procedures.
  • Must have a clear central cornea.
  • VA correctable to 0.3 LogMar or better (driving vision)

Exclusion criteria

  • Systemic disease affecting ocular health.
  • Using systemic or topical medications.
  • Wear monovision, multifocal or toric contact lenses.
  • Any grade 2 or greater slit lamp findings.
  • Pregnancy

Treatment and study plan

Bausch & Lomb Multi-Purpose Solution

Device

Daily care for contact lenses.

Primary outcomes

  1. Antimicrobial Efficacy

    Time frame: 2 weeks, 3 months

    Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae

Secondary outcomes

  1. Solution Related AE's and Lens Changes

    Time frame: 3 months, 6 months

    Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.

  2. Solution Utlility

    Time frame: 3 months, 6 months

    The Utility was determined based on the results of the efficacy and safety evaluations.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 8, 2008
Registry last updated
Dec 13, 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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