Effect of an Investigational Multi-Purpose Solution on Lens Moisture

Alcon

Status: Completed

Conditions: Contact Lens Moisture

Treatments: Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS); Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Silicone Hydrogel Contact Lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01341990

C-09-031

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture of silicone hydrogel contact lenses.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older.
• Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
• Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
• Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• Known sensitivity or intolerance to contact lens multi-purpose solutions.
• Use of any topical ocular OTC or prescribed topical ocular medications.
• History or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• Medical condition or use of medication that cause ocular side effects.
• Participation in any investigational study within the past 30 days.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 2 patient groups

FID 114675A

Experimental group

Description:

Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses

Treatment:

Device: Silicone Hydrogel Contact Lenses

Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)

ReNu MultiPlus

Active Comparator group

Description:

Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses

Treatment:

Device: Silicone Hydrogel Contact Lenses

Device: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)