Clear Care® Plus vs. PeroxiClear™

• ClinicalTrials.gov Identifier: NCT02413333
• Recruitment Status: Completed
• First Posted: April 9, 2015
• Results First Posted: September 19, 2016
• Last Update Posted: September 19, 2016
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Refractive Error	Device: Clear Care Plus contact lens solution; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
• Study Start Date: April 2015
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Mean Residual Peroxide at Day 30 [ Time Frame: 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 :

1. Mean Osmolality in Lens Cases at Day 30 [ Time Frame: 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).

Eligibility Criteria

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

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;
• 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.

Contacts and Locations

Sponsors and Collaborators

Alcon Research

Investigators

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

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02413333
• Other Study ID Numbers: LCD913-P001
• First Posted: April 9, 2015
• Results First Posted: September 19, 2016
• Last Update Posted: September 19, 2016
• Last Verified: July 2016

Keywords provided by Alcon Research:

Contact lens solution

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases; Contact Lens Solutions; Pharmaceutical Solutions; Disinfectants; Anti-Infective Agents