Clear Care® Plus vs. PeroxiClear™

NCT02413333 | Completed Results

• 1 other identifier: LCD913-P001
• Study Type: interventional
• Target: 133
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

Contact lens solution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean Osmolality in Lens Cases at Day 30

  Day 30, each product

Study Arms (2)

Clear Care Plus, then PeroxiClear

OTHER

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; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses

PeroxiClear, then Clear Care Plus

OTHER

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; Device: PeroxiClear contact lens solution; Device: Silicone hydrogel contact lenses

Interventions

Clear Care Plus contact lens solution DEVICE

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

Also known as: Clear Care Plus

Clear Care Plus, then PeroxiClear; PeroxiClear, then Clear Care Plus

PeroxiClear contact lens solution DEVICE

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

Also known as: PeroxiClear

Clear Care Plus, then PeroxiClear; PeroxiClear, then Clear Care Plus

Silicone hydrogel contact lenses DEVICE

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

Clear Care Plus, then PeroxiClear; PeroxiClear, then Clear Care Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Global Medical Affairs Franchise Head, Vision Care
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Manager, Vision Care, Global Medical Affairs

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 19, 2016
• Results First Posted: September 19, 2016

Record last verified: 2016-07