Clear Care® Plus vs. PeroxiClear™

NCT ID: NCT02413333

Last Updated: 2016-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-08-31

Brief Summary

The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.

Detailed Description

Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Clear Care Plus, then PeroxiClear

Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.

Group Type: OTHER

Clear Care Plus contact lens solution

Intervention Type: DEVICE

3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses

PeroxiClear contact lens solution

Intervention Type: DEVICE

3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses

Silicone hydrogel contact lenses

Intervention Type: DEVICE

2-week/monthly replacement contact lenses per participant's habitual brand

PeroxiClear, then Clear Care Plus

PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.

Group Type: OTHER

Clear Care Plus contact lens solution

Intervention Type: DEVICE

3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses

PeroxiClear contact lens solution

Intervention Type: DEVICE

3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses

Silicone hydrogel contact lenses

Intervention Type: DEVICE

2-week/monthly replacement contact lenses per participant's habitual brand

Interventions

Clear Care Plus contact lens solution

3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses

Intervention Type: DEVICE

PeroxiClear contact lens solution

3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses

2-week/monthly replacement contact lenses per participant's habitual brand

Intervention Type: DEVICE

Other Intervention Names

Clear Care Plus; PeroxiClear

Eligibility Criteria

Inclusion Criteria

• Sign informed consent form;
• Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
• Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
• Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;

Exclusion Criteria

• Current hydrogen peroxide-based solution user;
• Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• History of herpetic keratitis, ocular surgery, or irregular cornea;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Manager, Vision Care, Global Medical Affairs

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

LCD913-P001

Identifier Type: -

Identifier Source: org_study_id