Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

Alcon

Status: Completed

Conditions: Symptomatic Contact Lens Wearers

Treatments: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01187355

C-09-074

Details and patient eligibility

About

The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.

Enrollment: 591 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
• Vision correctable to 20/30 or better with contact lenses.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Sensitivity to multi-purpose solutions.
• Use of any topical ocular OTC or prescribed topical ocular medications.
• History (6 months) or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• Medical condition or use of medications 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: Double Blind

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591 participants in 2 patient groups

Alcon MPDS

Experimental group

Description:

MPDS used for 30 days as specified in protocol for contact lens care.

Treatment:

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

Device: Contact lenses

renu fresh MPS

Active Comparator group

Description:

MPS used for 30 days as indicated for contact lens care.

Treatment:

Device: renu fresh Multi-Purpose Solution (MPS)

Device: Contact lenses