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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Soft contact lens; Drug: Marketed soft lens multipurpose disinfection regimen

• Study Type: Interventional
• Enrollment: 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective of this study is to compare 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.

Secondary Outcome Measures

Outcome Measure
The secondary objective of this study is to compare subjective ocular symptoms
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.

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Craig Woods, PhD, University of Waterloo; Principal Investigator: Desmond Fonn, MOptom, University of Waterloo

Study record dates

Study Major Dates

• Study Start: June 1, 2005

Study Registration Dates

• First Submitted: July 5, 2006
• First Submitted That Met QC Criteria: July 5, 2006
• First Posted (Estimate): July 10, 2006

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P/211/04/L