Comparison of 3 Novel Contact Lens Solutions on the Basal Lamina

Alcon

Status: Completed

Conditions: Contact Lens Solution

Treatments: Device: Opti-Free contact lens solution; Device: Clear Care contact lens solution; Device: ReNu Multiplus contact lens solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00691457

SMA-08-09

Details and patient eligibility

About

Three arm study comparing three novel contact lens solutions.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Stable distance contact lens prescription between -0.50 D and 9.00 D and astigmatism less than or equal to -1.00 D cylindrical (cyl).
• Stable correction is defined as longer than six months.
• Worn a single brand of disposable silicone hydrogel contact lenses successfully (i.e., without complications or discomfort) for a minimum of six months

Exclusion:

• Known sensitivity to the contact lens disinfecting solutions or fluorescein dye.
• Any systemic or ocular disease that could affect contact lens wear.
• Women who are pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 3 patient groups

1

Experimental group

Description:

Opti-Free contact lens solution

Treatment:

Device: Opti-Free contact lens solution

2

Active Comparator group

Description:

ReNu Multiplus contact lens solution

Treatment:

Device: ReNu Multiplus contact lens solution

3

Active Comparator group

Description:

Clear Care contact lens solution

Treatment:

Device: Clear Care contact lens solution