Contact Lens Wettability

NCT00349063 | Completed Phase 4

• 1 other identifier: P/217/05/L
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ametropia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Interventions

soft contact lens DEVICE

Soft contact lens multipurpose disinfection regimen DRUG

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has had an oculo-visual examination in the last two years.
• 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.
• \. 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.
• \. Has a refractive error that is correctable with the prescription of the available study lenses.
• \. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.
• \. Has acceptable fit with the study lenses. 9. Has clear corneas, and ocular clinical findings are considered "normal".

You may not qualify if:

• Has any systemic disease that may affect ocular health.
• Is using any systemic or topical medications that may affect ocular health.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that may affect the wearing of contact lenses.
• Has any clinically significant lid or conjunctival abnormalities, meibomian gland dysfunction, neovascularization, corneal scars or corneal opacities.
• Has limbal injection, bulbar injection or corneal staining that, in the investigator's opinion, is clinically significant.
• Has pinguecula and/or pterygium that, in the investigator's judgement, makes contact lens wear inadvisable.
• Has refractive astigmatism of more than 0.75 D.
• Has corneal distortion resulting from rigid lens wear.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of clinical or research study.
• Is pregnant or lactating.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Refractive Errors

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Craig Woods, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

• Desmond Fonn, MOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 4, 2006
• First Posted: July 6, 2006
• Study Start: July 1, 2005
• Last Updated: July 19, 2006

Record last verified: 2006-07

Locations

CA (1)