CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

Alcon

Status: Completed

Conditions: Presbyopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02965833

LCS739-P001

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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126 participants in 2 patient groups

CCP, then HMPS

Other group

Description:

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.

Treatment:

Device: Habitual Multi-Purpose Contact Lens Solution

Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix

Device: Habitual Contact Lenses

HMPS, then CCP

Other group

Description:

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.

Treatment:

Device: Habitual Multi-Purpose Contact Lens Solution

Device: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix

Device: Habitual Contact Lenses