Clinical trial NCT00349063: Contact Lens Wettability
Official title: The Impact of Short Term Wearing Time on In Vivo and Ex Vivo Wettability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ametropia
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2006-07-06
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: To investigate the impact of wearing time and contact lens care solutions on in
measure: vivo and ex vivo wettability of currently marketed contact lenses
Secondary outcomes:
measure: To determine if there is a correlation between in vivo wettability, ex vivo
measure: wettability and in-eye comfort. To determine if comfort and wettability vary
measure: between symptomatic and asymptomatic lens wearers.
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Craig Woods, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo
name: Desmond Fonn, MOptom
role: PRINCIPAL_INVESTIGATOR
References: