Corneal and Conjunctival Sensitivity and Staining Study

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo
ClinicalTrials.gov Identifier:
NCT00455455
First received: March 23, 2007
Last updated: June 9, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Myopia
Hyperopia
Drug: Optifree RepleniSH Multipurpose Disinfecting Solution
Drug: ReNu Multiplus Multipurpose Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Corneal and Conjunctival Sensitivity and Staining Study

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Corneal Sensitivity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Corneal Sensitivity [ Time Frame: day 7 ] [ Designated as safety issue: No ]
    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.

  • Conjunctival Sensitivity [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Conjunctival Sensitivity [ Time Frame: day 7 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Corneal Staining Grade [ Time Frame: baseline ] [ Designated as safety issue: No ]
    A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).

  • Corneal Staining Grade [ Time Frame: day 7 ] [ Designated as safety issue: No ]
    A 0-100 grading scale based on the extent of corneal staining (0 none, 100 full area).


Enrollment: 50
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Optifree RepleniSH Multipurpose Disinfecting Solution Drug: Optifree RepleniSH Multipurpose Disinfecting Solution
lens care system
Other Name: lens care system
Active Comparator: ReNu Multiplus Multipurpose Solution Drug: ReNu Multiplus Multipurpose Solution
lens care system
Other Name: lens care system

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455455

Locations
Canada, Ontario
Centre for Contact Lens Research, School of Optometry
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Principal Investigator: Desmond Fonn, M.Optom University of Waterloo
  More Information

No publications provided by University of Waterloo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Craig Woods, Research Manager, Centre for Contact Lens Research
ClinicalTrials.gov Identifier: NCT00455455     History of Changes
Other Study ID Numbers: P/245/06/L
Study First Received: March 23, 2007
Results First Received: January 5, 2010
Last Updated: June 9, 2010
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hyperopia
Myopia
Refractive Errors
Eye Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014