Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens

Myopia Clinical Trial

— Amethyst  

Official title:

Multipurpose Solution Compatibility With a Silicone Hydrogel Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520689
• Other study ID #: P/264/07/M
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2007
• Last updated: February 12, 2009
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• 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 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).

Description:

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) by observing changes within the cornea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years to 55 Years

Eligibility

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years old and has full legal capacity to volunteer

2. Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers

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

4. Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision 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 two years.

8. Has a functional pair of spectacles

9. Is a current soft lens wearer replacing their lenses at least monthly

10. Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens

11. Has astigmatism less than or equal to -1.00DC

12. Agrees to wear the study lenses on a daily wear basis

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Has any signs or symptoms of dry eye

2. Has any clinically significant blepharitis

3. Has undergone corneal refractive surgery

4. Is aphakic

5. Has any systemic disease affecting ocular health

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

7. Is pregnant or lactating

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

9. Currently wears daily disposable lenses

10. Currently wears lenses on a continuous or extended wear basis

11. Is unable to successfully wear contact lenses without routinely using rewetting drops

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Silicone Hydrogel Contact Lens
use of lens over 2 days

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Menicon Co., Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To see if there are any effects on the cornea when using each contact lens/solution combination.		Over 2 days	Yes
Secondary	To quantify comfort and vision ratings with each lens/solution combination.		over 2 days	Yes