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OpenTrials
Completed

NCT Number: NCT01294917

Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

About this study

This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Has had an ocular examination in the last two years;
  • Is a current soft lens wearer using either two-week or monthly replacement lenses;
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
  • Has normal binocular vision (no strabismus, no amblyopia);
  • Has clear corneas and no active ocular disease;
  • Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
  • Has astigmatism less than or equal to -1.00 D;
  • Agrees to wear the study lenses on a daily wear basis.

Exclusion criteria

  • Has any active ocular disease;
  • Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
  • Has undergone corneal refractive surgery;
  • Has a systemic condition that may affect a study outcome variable;
  • Is using any systemic or topical medications that may affect ocular health;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Is pregnant or lactating;
  • Is participating in any other clinical or research study that may affect a study outcome variable;
  • Currently wears daily disposable lenses or extended wear lenses.

Treatment and study plan

Multi-purpose disinfecting solution

Device

For the cleaning, rinsing, and storage of soft contact lenses.

CLEAR CARE

Device

Peroxide-based regimen for cleaning and disinfecting soft contact lenses.

OPTI-FREE RepleniSH

Device

Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.

Primary outcomes

  1. Corneal Staining

    Time frame: 4 weeks

    Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.

Secondary outcomes

  1. Subjective Lens Wearing Comfort

    Time frame: 4 weeks

    This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.

  2. Dryness

    Time frame: 4 weeks

    This will be assessed by the tear break-up time on the lens surface, measured in seconds.

Sponsors and collaborators

Lead sponsor

Abbott Medical Optics

Industry

Registry information

Official study title

Comparison of a New AMO MPS to Existing Contact Lens Regimens

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 14, 2011
Registry last updated
Mar 6, 2017

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.