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OpenTrials
Completed

NCT Number: NCT00455455

Corneal and Conjunctival Sensitivity and Staining Study

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

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Key information

Age range

17 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Contact Lens Research, School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

About this study

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens. Observations will be made to monitor physiology.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

An eligible participant is one who:

  • Is between 17-45 years old and has full legal capacity to volunteer.
  • Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)
  • Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.
  • Has normal binocular vision (no strabismus, no amblyopia).
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.
  • Has astigmatism less than or equal to -1.00DC.
  • Agrees to wear the study lenses on a daily wear basis.
  • Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion criteria

A person is ineligible if he/she:

  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has a 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.
  • Has a known clinically significant sensitivity to the contact lens care solutions used in the study.
  • Has ocular or systemic allergies that could adversely affect contact lens wear.
  • Currently wears lenses on a continuous or extended wear basis.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
  • Has pinguecula/pterygium that, in the investigator's judgment, makes contact lens wear inadvisable.
  • Is a rigid lens wearer.
  • Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.

Treatment and study plan

Optifree RepleniSH Multipurpose Disinfecting Solution

Drug

lens care system

Other names: lens care system

ReNu Multiplus Multipurpose Solution

Drug

lens care system

Other names: lens care system

Primary outcomes

  1. Corneal Sensitivity

    Time frame: baseline

    The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

  2. Corneal Sensitivity

    Time frame: day 7

    The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

  3. Conjunctival Sensitivity

    Time frame: baseline

    The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

  4. Conjunctival Sensitivity

    Time frame: day 7

    The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

Secondary outcomes

  1. Corneal Staining Grade

    Time frame: baseline

    A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

  2. Corneal Staining Grade

    Time frame: day 7

    A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Apr 3, 2007
Registry last updated
Jul 12, 2010

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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