Contact Lens Wettability

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

Study Description

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

• 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

Arms and Interventions

Outcome Measures

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

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• 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

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

• ClinicalTrials.gov Identifier: NCT00349063
• Other Study ID Numbers: P/217/05/L
• First Posted: July 6, 2006
• Last Update Posted: July 19, 2006
• Last Verified: July 2006

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases