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Contact Lens Wettability

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ClinicalTrials.gov Identifier: NCT00349063
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : July 19, 2006
Sponsor:
Collaborator:
Alcon Research
Information provided by:
University of Waterloo

Study Description
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Brief Summary:
The purpose of this study is to compare the wettability of contact lenses disinfected with three marketed contact lens care solutions.

Condition or disease Intervention/treatment Phase
Ametropia Device: soft contact lens Drug: Soft contact lens multipurpose disinfection regimen Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To investigate the impact of wearing time and contact lens care solutions on in
  2. vivo and ex vivo wettability of currently marketed contact lenses

Secondary Outcome Measures :
  1. To determine if there is a correlation between in vivo wettability, ex vivo
  2. wettability and in-eye comfort. To determine if comfort and wettability vary
  3. between symptomatic and asymptomatic lens wearers.

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Has had an oculo-visual examination in the last two years.
  2. Is at least 18 years old and has full legal capacity to volunteer or is at least 16 years old, has a parent or guardian’s permission to participate in the study and has read the Information and Consent Letter for adolescents.

4. Has read and understood the Information Consent Letter (Appendix II). 5. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.

6. Has a refractive error that is correctable with the prescription of the available study lenses.

7. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.

8. Has acceptable fit with the study lenses. 9. Has clear corneas, and ocular clinical findings are considered “normal”.

Exclusion Criteria:

  1. Has any systemic disease that may affect ocular health.
  2. Is using any systemic or topical medications that may affect ocular health.
  3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
  4. Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
  5. Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
  6. Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable.
  7. Has refractive astigmatism of more than 0.75 D.
  8. Has corneal distortion resulting from rigid lens wear.
  9. Is aphakic.
  10. Has undergone corneal refractive surgery.
  11. Is participating in any other type of clinical or research study.
  12. Is pregnant or lactating.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349063


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00349063     History of Changes
Other Study ID Numbers: P/217/05/L
First Posted: July 6, 2006    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases