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Comparison of Lens Care Regimens With a Silicone Hydrogel Lens
This study is currently recruiting participants.
Verified by University of Waterloo, August 2007
Sponsors and Collaborators: University of Waterloo
Alcon Research
Information provided by: University of Waterloo
ClinicalTrials.gov Identifier: NCT00520351
  Purpose

The purpose of the study is to evaluate and compare, on a daily wear basis, the performance of two contact lens care solutions when used with silicone hydrogel soft contact lenses with regards to comfort and dryness symptoms.


Condition Intervention Phase
Myopia
Drug: Optifree Replenish
Drug: Clear Care
Phase III

MedlinePlus related topics: Eye Wear
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Comparison of Lens Care Regimens With a Silicone Hydrogel Lens

Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • To determine the performance for the two lens care products [ Time Frame: six months ]

Estimated Enrollment: 30
Study Start Date: August 2007
Estimated Study Completion Date: September 2008
Arms Assigned Interventions
1: Active Comparator Drug: Optifree Replenish
2: Active Comparator Drug: Clear Care

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  1. Is at least 17 years of age and has full legal capacity to volunteer.
  2. Has read, understood and signed an information consent letter.
  3. Is willing and able to follow instructions and maintain the appointment schedule.
  4. Is presently using either bi-weekly or monthly replacement lenses.
  5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.
  6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  7. Has clear corneas and no active ocular disease.
  8. Has had an ocular examination in the last two years.

Exclusion Criteria:

A person will be excluded from the study if he/she:

  1. Is an asymptomatic lens wearer.
  2. Is a daily disposable contact lens wearer.
  3. Is a current extended wear contact lens wearer.
  4. Currently uses one of the study lens care regimens.
  5. Has any clinically significant blepharitis.
  6. Has undergone corneal refractive surgery.
  7. Is aphakic.
  8. Has any active ocular disease.
  9. Has any systemic disease affecting ocular health.
  10. Is using any systemic or topical medications that may affect ocular health.
  11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  12. Is participating in any other type of clinical or research study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520351

Contacts
Contact: Craig A Woods, PhD 1 519 888 4567 ext 36547 cvawoods@uwaterloo.ca

Locations
Canada, Ontario
Centre for Contact Lens Research, School of Optometry, University of Waterloo. Recruiting
Waterloo, Ontario, Canada, N2L3G1
Contact: Craig A Woods, PhD     1 519 888 4567 ext 36547     cawoods@uwaterloo.ca    
Sponsors and Collaborators
University of Waterloo
Alcon Research
Investigators
Principal Investigator: Desmond Fonn, M. Optom University of Waterloo
  More Information

Study ID Numbers: P/265/07/L
Study First Received: August 21, 2007
Last Updated: August 23, 2007
ClinicalTrials.gov Identifier: NCT00520351  
Health Authority: Canada: Health Canada

Study placed in the following topic categories:
Myopia

ClinicalTrials.gov processed this record on January 16, 2009