CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

Not Applicable

Completed

Conditions: Presbyopia

Interventions: Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix
Device: Habitual Multi-Purpose Contact Lens Solution
Device: Habitual Contact Lenses

Registration Number: NCT02965833

Lead Sponsor: Alcon, a Novartis Company

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 126

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CCP, then HMPS	Habitual Multi-Purpose Contact Lens Solution	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.
HMPS, then CCP	3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix	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.
HMPS, then CCP	Habitual Multi-Purpose Contact Lens Solution	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.
CCP, then HMPS	3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix	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.
CCP, then HMPS	Habitual Contact Lenses	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.
HMPS, then CCP	Habitual Contact Lenses	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.

Primary Outcome Measures

Name	Time	Method
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30	Day 30, each product	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.

Secondary Outcome Measures