Contact Lens Wettability

Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349063
• Other study ID #: P/217/05/L
• Status: Completed
• Phase: Phase 4
• First received: July 4, 2006
• Last updated: July 17, 2006
• Start date: July 2005

Study information

• Verified date: July 2006
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ametropia

Intervention

Device:
• soft contact lens

Drug:
• Soft contact lens multipurpose disinfection regimen

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the impact of wearing time and contact lens care solutions on in
Primary	vivo and ex vivo wettability of currently marketed contact lenses
Secondary	To determine if there is a correlation between in vivo wettability, ex vivo
Secondary	wettability and in-eye comfort. To determine if comfort and wettability vary
Secondary	between symptomatic and asymptomatic lens wearers.