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Completed

NCT Number: NCT02537730

BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study

Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kodama Eye Clinic, Joyo-shi, Kyoto, Japan

Loading trial locations.

About this study

To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Is over 18 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
  • Has less than 1.00 D spectacle cylinder in each eye
  • Is correctable to a visual acuity of 20/20 or better in both eyes
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the informed consent letter
  • Is willing to comply with the wear schedule (at least 40hrs per week)
  • Is willing to comply with the visit schedule

Exclusion criteria

  • Has never worn contact lenses before
  • Currently wears rigid gas permeable contact lens
  • Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day)
  • Has a CL prescription outside the range of -0.25D to -12.00D
  • Has a spectacle cylinder greater than -0.75D of cylinder in either eye
  • Has best corrected spectacle distant vision worse than 20/20 in ether eye
  • Has any systemic disease affecting ocular health
  • Is using any systemic or topical medications that will affect ocular health
  • Has any ocular pathology or sever insufficiency of lacrimal secretion
  • Has persistent, clinically significant corneal or conjunctival staining
  • Has active neovascularization or any central corneal scars
  • Is aphakic
  • Is pregnant or lactating

Treatment and study plan

Bioclean MPS VII

Device

PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system

Aosept Clearcare

Device

Hydrogen Peroxide Disinfecting and Cleaning system

comfilcon A

Device

contact lens

Other names: Biofinity

Primary outcomes

  1. Ocular Health - Corneal Staining

    Time frame: 1 week

    Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.

Secondary outcomes

  1. Comfort

    Time frame: 1 week

    Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.

  2. Dryness

    Time frame: 1 week

    Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent.

  3. Stinging and Burning Sensation

    Time frame: Baseline

    Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all.

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 2, 2015
Registry last updated
Aug 18, 2020

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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