Evaluation of an Investigational Multi-Purpose Disinfecting Solution for Care of Soft Contact Lenses

Alcon

Status: Completed

Conditions: Contact Lens Care

Treatments: Device: FID 107027 Multi-Purpose Disinfecting Solution; Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT00382681

C-03-41

Details and patient eligibility

About

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.

Enrollment: 252 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
• Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
• Successful lens wear for at least 8 hours per day.
• Vision correctable to 20/30.
• Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
• No corneal surgery within the past 12 months.
• No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
• No over-the-counter or prescription ocular medication.
• No enrollment in another clinical study within 30 days prior to enrollment.

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

FID 107027

Experimental group

Description:

Contact lens solution used as instructed for 90 days.

Treatment:

Device: FID 107027 Multi-Purpose Disinfecting Solution

ReNu MultiPlus

Active Comparator group

Description:

Contact lens solution used as instructed for 90 days.

Treatment:

Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula