Clear Care® Plus vs. PeroxiClear™

Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Clear Care Plus contact lens solution; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;
• Other protocol-specified inclusion criteria may apply.

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;
• Other protocol-specified exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Clear Care Plus contact lens solution; 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses; Other Names: Clear Care Plus; Device: PeroxiClear contact lens solution; 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses; Other Names: PeroxiClear; Device: Silicone hydrogel contact lenses; 2-week/monthly replacement contact lenses per participant's habitual brand
Other: 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.	Device: Clear Care Plus contact lens solution; 3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses; Other Names: Clear Care Plus; Device: PeroxiClear contact lens solution; 3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses; Other Names: PeroxiClear; Device: Silicone hydrogel contact lenses; 2-week/monthly replacement contact lenses per participant's habitual brand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Residual Peroxide at Day 30	The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).	Day 30, each product

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Osmolality in Lens Cases at Day 30	The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).	Day 30, each product

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Vision Care, Global Medical Affairs, Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 7, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Estimate): September 19, 2016
• Last Update Submitted That Met QC Criteria: July 29, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Contact lens solution
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Anti-Infective Agents; Disinfectants; Pharmaceutical Solutions; Contact Lens Solutions
• Other Study ID Numbers: LCD913-P001