Effects of Contact Lens Care Regimens on the Corneal Epithelium

University of Waterloo

Status and phase: Completed; Phase 4

Conditions: Myopia

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00349882

P/216/05/L

Details and patient eligibility

About

The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is at least 18 years old and has full legal capacity to volunteer.

2. Has read, understood and signed an Information Consent Letter.

3. Is willing and able to follow instructions and maintain the appointment schedule.

4. Is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual correction.

5. Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D).

6. Has clear corneas and no active ocular disease.

7. Has had an ocular examination in the last 2 years.

8. Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months.

   An ineligible contact lens wearer is one who:

9. Responds positively to points 1 to 7 above.

10. Has a distance contact lens prescription between -0.50D and -9.00 D.

11. Has astigmatism less than or equal to -1.00D cyl.

12. Currently wears silicone hydrogel contact lenses successfully.

13. Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.

Exclusion criteria

1. Has undergone corneal refractive surgery.

2. Is aphakic.

3. Has any active ocular disease.

4. Has any systemic disease affecting ocular health.

5. Is using any systemic or topical medications that may affect ocular health.

6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

7. Is pregnant or lactating.

8. Is participating in any other type of clinical or research study.

   An ineligible contact lens wearer is one who:

9. Responds positively to any of points 1 to 8 above for exclusion criteria.

10. Has known sensitivity to the contact lens care solutions used in the study.

11. Has ocular or systemic allergies that could adversely affect contact lens wear.

12. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.

13. Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind