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

NCT ID: NCT01912768

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-05-31

Brief Summary

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.

Detailed 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).

Conditions

Myopia; Astigmatism; Hyperopia; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

FID 120947A

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

Group Type: EXPERIMENTAL

FID 120947A contact lens disinfecting solution

Intervention Type: DEVICE

Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses

Soft contact lenses

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 (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

renu fresh

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

Group Type: ACTIVE_COMPARATOR

renu fresh multi-purpose solution

Intervention Type: DEVICE

Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses

Soft contact lenses

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 (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

Interventions

FID 120947A contact lens disinfecting solution

Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses

Intervention Type: DEVICE

renu fresh multi-purpose solution

Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses

Intervention Type: DEVICE

Soft contact lenses

Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

Intervention Type: DEVICE

Other Intervention Names

Clear Care® Plus

Eligibility Criteria

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;

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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monica Studzinski, Lead CSM

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-13-003

Identifier Type: -

Identifier Source: org_study_id