Clinical Evaluation of the Safety and Efficacy of FID 120947A

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: SCL preservative solution; Device: FID 120947A contact lens disinfecting solution; Device: Soft contact lenses (SCL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02771145

LCE293-C001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.

Enrollment: 91 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1;
• Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye;
• Other protocol-specified 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;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable);
• History of intolerance or hypersensitivity to any component of the investigational products;
• Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study;
• Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings;
• Corneal vascularization that is mild (grade 2) or higher;
• Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1;
• Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1;
• Any systemic disease (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 for a minimum of 30 days prior to Visit 1;
• Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs);
• Participation in any investigational clinical study within 30 days of Visit 1;
• Other protocol-specified 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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91 participants in 1 patient group

FID 120947A

Experimental group

Description:

FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 180 days. SCL preservative solution used standard-of-care.

Treatment:

Device: SCL preservative solution

Device: Soft contact lenses (SCL)

Device: FID 120947A contact lens disinfecting solution