Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens (Amethyst)

University of Waterloo

Status and phase: Completed; Phase 3

Conditions: Myopia; Hyperopia

Treatments: Device: Silicone Hydrogel Contact Lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00520689

P/264/07/M

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 17 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 4 patient groups

1

Active Comparator group

Treatment:

Device: Silicone Hydrogel Contact Lens

2

Active Comparator group

Treatment:

Device: Silicone Hydrogel Contact Lens

3

Active Comparator group

Treatment:

Device: Silicone Hydrogel Contact Lens

4

Active Comparator group

Treatment:

Device: Silicone Hydrogel Contact Lens