CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Habitual Multi-Purpose Contact Lens Solution; Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix; Device: Habitual Contact Lenses

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must sign an informed consent document;
• Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
• Near spectacle add of +0.50 or greater;
• Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
• Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
• Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;
• Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
• Other protocol-specific inclusion criteria may apply.

Exclusion Criteria:

• Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
• Prior refractive surgery;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Pathological dry eye that precludes contact lens wear;
• Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
• Participation in any clinical study within 30 days of Visit 1;
• Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
• Other protocol-specific exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CCP, then HMPS; 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.	Device: Habitual Multi-Purpose Contact Lens Solution; Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix; For cleaning, disinfection and overnight storage of contact lenses; Other Names: CLEAR CARE® PLUS; Device: Habitual Contact Lenses; Participant's habitual contact lens brand worn in a daily wear modality for 30 days.
Other: HMPS, then CCP; Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.	Device: Habitual Multi-Purpose Contact Lens Solution; Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix; For cleaning, disinfection and overnight storage of contact lenses; Other Names: CLEAR CARE® PLUS; Device: Habitual Contact Lenses; Participant's habitual contact lens brand worn in a daily wear modality for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30	CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.	Day 30, each product

Collaborators and Investigators

• Sponsor: Alcon, a Novartis Company

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2016
• Primary Completion (Actual): March 24, 2017
• Study Completion (Actual): March 24, 2017

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: November 15, 2016
• First Posted (Estimate): November 17, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Contact lens induced dryness
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Pharmaceutical Solutions; Hydrogen Peroxide; Contact Lens Solutions
• Other Study ID Numbers: LCS739-P001