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Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort
This study has been completed.

First Received on July 5, 2006.   No Changes Posted
Sponsor: University of Waterloo
Collaborator: Alcon Research
Information provided by: University of Waterloo
ClinicalTrials.gov Identifier: NCT00349843
  Purpose

The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.


Condition Intervention Phase
Myopia
Device: Soft contact lens
Drug: Marketed soft lens multipurpose disinfection regimen
Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • The primary objective of this study is to compare corneal staining over time in
  • a group of individuals who wear soft contact lenses on a daily wear basis,
  • whilst they sequentially use two different contact lens care regimens.

Secondary Outcome Measures:
  • The secondary objective of this study is to compare subjective ocular symptoms
  • over time in a group of individuals who wear soft contact lenses on a daily wear
  • basis, whilst they sequentially use two different contact lens care regimens.

Estimated Enrollment: 30
Study Start Date: June 2005
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  1. Agrees to wear the study lenses on a daily wear basis without the use of ocular lubricants.
  2. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.
  3. Is correctable to a visual acuity of 6/6 or better with their habitual correction.
  4. Is willing and able to follow product usage instructions and maintain the visit schedule.
  5. Is at least 18 years of age and has full legal capacity to volunteer.
  6. Can be successfully fitted with study lens type.
  7. Has read, understood and signed an Information Consent Letter.
  8. Has a distance contact lens prescription is between –0.50 D and –9.00 D
  9. Has astigmatism of  1.00 D Cyl
  10. Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of  1.00D
  11. Has no systemic disease affecting ocular health.
  12. Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.
  13. Has clear corneas and no active ocular disease.
  14. Has no known ocular or systemic allergies, which could interfere with contact lens wear.
  15. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator’s opinion is clinically significant.
  16. Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.
  17. Has not worn extended wear contact lenses in the last 30 days.
  18. Has had an oculo-visual examination in the last two years

Exclusion Criteria:

  1. Has any active ocular disease.
  2. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.
  3. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)
  4. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)
  5. Is using topical ocular prescription or any topical over-the-counter medication.
  6. Is actively involved in any other research/clinical study.
  7. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.
  8. Has had corneal refractive surgery.
  9. Has known sensitivity to any of the study solutions.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349843

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Principal Investigator: Craig Woods, PhD University of Waterloo
Principal Investigator: Desmond Fonn, MOptom University of Waterloo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00349843     History of Changes
Other Study ID Numbers: P/211/04/L
Study First Received: July 5, 2006
Last Updated: July 5, 2006
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012