Lens Wearing Experience and Biocompatibility of a Marketed Multi-Purpose Disinfecting Solution in Silicone Hydrogel and Soft Contact Lens Wearers

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: OPTI-FREE PureMoist

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484938

C-10-017

Details and patient eligibility

About

The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Soft contact lens wear on a daily wear basis
• Able to wear contact lenses for at least 8 hours
• Generally healthy and have normal ocular health
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• No use of additional lens cleaners
• No known sensitivities to any ingredient in the test article
• No history of ocular surgery/trauma within the last six months
• Other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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175 participants in 1 patient group

OPTI-FREE

Experimental group

Description:

OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen

Treatment:

Device: OPTI-FREE PureMoist