Clear Care® Plus vs. PeroxiClear™

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Clear Care Plus contact lens solution; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses

• Registration Number: NCT02413333
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-07
• Results First Submitted: 2016-07-29
• Results First Submitted QC: 2016-07-29
• Last Update Submitted: 2016-07-29
• Results First Posted: 2016-09-19
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PeroxiClear, then Clear Care Plus	Clear Care Plus contact lens solution	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.
Clear Care Plus, then PeroxiClear	Clear Care Plus contact lens solution	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.
Clear Care Plus, then PeroxiClear	PeroxiClear contact lens solution	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.
Clear Care Plus, then PeroxiClear	Silicone hydrogel contact lenses	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.
PeroxiClear, then Clear Care Plus	PeroxiClear contact lens solution	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.
PeroxiClear, then Clear Care Plus	Silicone hydrogel contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Mean Residual Peroxide at Day 30	Day 30, each product	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).

Secondary Outcome Measures

Name	Time	Method
Mean Osmolality in Lens Cases at Day 30	Day 30, each product	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).