Clinical Evaluation of the Safety and Efficacy of FID 120947A

NCT ID: NCT02771145

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-20
• Study Completion Date: 2017-01-10

Brief Summary

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

Conditions

Refractive Error

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

FID 120947A

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.

Group Type: EXPERIMENTAL

FID 120947A contact lens disinfecting solution

Intervention Type: DEVICE

Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses

Soft contact lenses (SCL)

Intervention Type: DEVICE

Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.

SCL preservative solution

Intervention Type: DEVICE

Commercially available solution for rinsing soft contact lenses

Interventions

FID 120947A contact lens disinfecting solution

Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses

Intervention Type: DEVICE

Soft contact lenses (SCL)

Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.

Intervention Type: DEVICE

SCL preservative solution

Commercially available solution for rinsing soft contact lenses

Intervention Type: DEVICE

Other Intervention Names

Clear Care® Plus; 2-Week Acuvue®

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Group Manager, Clinical Development

Role: STUDY_DIRECTOR

Alcon Japan, Ltd.

Locations

Contact Alcon Japan, Ltd. for Trial Locations

Tokyo, , Japan

Countries

Japan

Other Identifiers

LCE293-C001

Identifier Type: -

Identifier Source: org_study_id