Contact Lens Wettability

University of Waterloo

Status and phase: Completed; Phase 4

Conditions: Ametropia

Treatments: Drug: Soft contact lens multipurpose disinfection regimen; Device: soft contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00349063

P/217/05/L

Details and patient eligibility

About

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

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

3. 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.

4. Has a refractive error that is correctable with the prescription of the available study lenses.

5. Has a refractive error that is correctable to at least 20/25 distance visual acuity with contact lenses in each eye.

6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind