Clear Care® Plus vs. PeroxiClear™

Refractive Error Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413333
• Other study ID #: LCD913-P001
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: August 18, 2015
• Start date: April 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Clear Care® Plus contact lens cleaning and disinfecting solution
Hydrogen peroxide 3% solution for cleaning, disinfection and overnight storage of contact lenses
• PeroxiClear™ contact lens cleaning and disinfecting solution
Hydrogen peroxide 3% solution for cleaning, disinfection and overnight storage of contact lenses
• Silicone hydrogel contact lenses
2-week/monthly replacement contact lenses per subject's habitual brand

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean residual peroxide at Day 30	Residual peroxide of the lens solution will be assessed after neutralization at disinfection time in the used lens cases collected at Day 30.	Day 30 (each product)	No
Secondary	Mean osmolality at Day 30	Osmolality of the lens solution will be assessed after neutralization at disinfection time in the used lens cases collected at Day 30.	Day 30 (each product)	No