Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

NCT00520689 | Completed Phase 3

• 1 other identifier: P/264/07/M
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).

Conditions

Myopia; Hyperopia

Outcome Measures

Primary Outcomes (1)

• To see if there are any effects on the cornea when using each contact lens/solution combination.

  Over 2 days

Secondary Outcomes (1)

• To quantify comfort and vision ratings with each lens/solution combination.

  over 2 days

Study Arms (4)

1

ACTIVE COMPARATOR

Device: Silicone Hydrogel Contact Lens

2

ACTIVE COMPARATOR

Device: Silicone Hydrogel Contact Lens

3

ACTIVE COMPARATOR

Device: Silicone Hydrogel Contact Lens

4

ACTIVE COMPARATOR

Device: Silicone Hydrogel Contact Lens

Interventions

Silicone Hydrogel Contact Lens DEVICE

use of lens over 2 days

Also known as: Premio

1; 2; 3; 4

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Is at least 17 years old and has full legal capacity to volunteer
• Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
• Is willing and able to follow instructions and maintain the study appointment schedule
• Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
• Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
• Has clear corneas and no active ocular disease
• Has had an ocular examination in the last two years.
• Has a functional pair of spectacles
• Is a current soft lens wearer replacing their lenses at least monthly
• Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
• Has astigmatism less than or equal to -1.00DC
• Agrees to wear the study lenses on a daily wear basis

You may not qualify if:

• A person will be excluded from the study if he/she:
• Has any signs or symptoms of dry eye
• Has any clinically significant blepharitis
• Has undergone corneal refractive surgery
• Is aphakic
• Has any systemic disease affecting ocular health
• Is using any systemic or topical medications that may affect ocular health
• Is pregnant or lactating
• Is participating in any other type of clinical or research study
• Currently wears daily disposable lenses
• Currently wears lenses on a continuous or extended wear basis
• Is unable to successfully wear contact lenses without routinely using rewetting drops

Sponsors & Collaborators

• University of Waterloo: lead
• Menicon Co., Ltd.: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Desmond Fonn, M Optom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

• Craig Woods, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 24, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

CA (1)