Contact Lens Wettability

The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability

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

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: soft contact lens; Drug: Soft contact lens multipurpose disinfection regimen

• Study Type: Interventional
• Enrollment: 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To investigate the impact of wearing time and contact lens care solutions on in
vivo and ex vivo wettability of currently marketed contact lenses

Secondary Outcome Measures

Outcome Measure
To determine if there is a correlation between in vivo wettability, ex vivo
wettability and in-eye comfort. To determine if comfort and wettability vary
between symptomatic and asymptomatic lens wearers.

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Craig Woods, PhD, University of Waterloo; Principal Investigator: Desmond Fonn, MOptom, University of Waterloo

Study record dates

Study Major Dates

• Study Start: July 1, 2005

Study Registration Dates

• First Submitted: July 4, 2006
• First Submitted That Met QC Criteria: July 4, 2006
• First Posted (Estimate): July 6, 2006

Study Record Updates

• Last Update Posted (Estimate): July 19, 2006
• Last Update Submitted That Met QC Criteria: July 17, 2006
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: P/217/05/L