Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort

Myopia Clinical Trial

Official title:

Investigation of Multi-Purpose Solution-Based Corneal Staining and Ocular Comfort With Daily Wear FDA Group IV Hydrogel Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349843
• Other study ID #: P/211/04/L
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2006
• Last updated: December 15, 2015
• Start date: June 2005

Study information

• Verified date: December 2015
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare subjective ocular symptoms and corneal staining over time in a group of individuals who wear soft contact lenses on a daily wear basis, whilst they sequentially use two different contact lens care regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

2. Has an up to date pair of glasses and is willing to wear these glasses at different times during the study.

3. Is correctable to a visual acuity of 6/6 or better with their habitual correction.

4. Is willing and able to follow product usage instructions and maintain the visit schedule.

5. Is at least 18 years of age and has full legal capacity to volunteer.

6. Can be successfully fitted with study lens type.

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

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

9. Has astigmatism of = 1.00 D Cyl

10. Has normal binocular vision, i.e. no strabismus, no amblyopia, and anisometropia of = 1.00D

11. Has no systemic disease affecting ocular health.

12. Is not using any systemic or topical medications that will affect ocular health, accommodative function, or the ocular physiological response to the contact lenses.

13. Has clear corneas and no active ocular disease.

14. Has no known ocular or systemic allergies, which could interfere with contact lens wear.

15. Has no lid or conjunctival abnormalities, neovascularization, limbal injection, bulbar injection or corneal staining, which in the investigator's opinion is clinically significant.

16. Has not worn rigid contact lenses in the last 30 days or has corneal distortion resulting from rigid lens wear.

17. Has not worn extended wear contact lenses in the last 30 days.

18. Has had an oculo-visual examination in the last two years

Exclusion Criteria:

1. Has any active ocular disease.

2. Has any lid or conjunctival abnormalities that may, in the opinion of the investigator, interfere with the wear of contact lenses.

3. Has edema, staining, clinically significant corneal opacity, dystrophy, vascularization or iritis as viewed by slit lamp. (Trace or grade 1 equivalent limbal and bulbar injection or corneal staining is permissible at the discretion of the investigator.)

4. Is using ocular lubricants or contact lens rewetting drops on a regular basis (at least once per day)

5. Is using topical ocular prescription or any topical over-the-counter medication.

6. Is actively involved in any other research/clinical study.

7. Has worn rigid lenses or soft lenses on an extended wear basis within the last 30 days.

8. Has had corneal refractive surgery.

9. Has known sensitivity to any of the study solutions.

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 soft lens 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 objective of this study is to compare corneal staining over time in
Primary	a group of individuals who wear soft contact lenses on a daily wear basis,
Primary	whilst they sequentially use two different contact lens care regimens.
Secondary	The secondary objective of this study is to compare subjective ocular symptoms
Secondary	over time in a group of individuals who wear soft contact lenses on a daily wear
Secondary	basis, whilst they sequentially use two different contact lens care regimens.