Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Alcon

Status: Completed

Conditions: Myopia; Refractive Error; Astigmatism; Hyperopia

Treatments: Device: Soft contact lenses; Device: renu fresh multi-purpose solution; Device: FID 120947A contact lens disinfecting solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01912768

C-13-003

Details and patient eligibility

About

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Full description

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Enrollment: 362 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal eyes (other than correction for visual acuity);
• Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
• Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;
• Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
• Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
• History of intolerance or hypersensitivity to any component of the investigational products;
• Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
• Moderate, severe, abnormal, or other ocular findings;
• Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
• Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
• Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
• Ocular surgery within the last 12 months;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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362 participants in 2 patient groups

FID 120947A

Experimental group

Description:

FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days

Treatment:

Device: FID 120947A contact lens disinfecting solution

Device: Soft contact lenses

renu fresh

Active Comparator group

Description:

Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days

Treatment:

Device: renu fresh multi-purpose solution

Device: Soft contact lenses