Effects of Contact Lens Care Regimens on the Corneal Epithelium

Myopia Clinical Trial

Official title:

Effects of Contact Lens Care Regimens on the Corneal Epithelium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349882
• Other study ID #: P/216/05/L
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2006
• Last updated: July 5, 2006
• Start date: June 2005

Study information

• Verified date: July 2006
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• soft contact lens

Drug:
• Marketed multipurpose disinfection regimen

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure of this study is to investigate the effects of two
Primary	different contact lens care solutions on the cornea.
Secondary	The secondary outcome measure of this study is to compare the subjective and
Secondary	objective responses between two different contact lens care solutions.