CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers

NCT ID: NCT02965833

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-13
• Study Completion Date: 2017-03-24

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix

Intervention Type: DEVICE

For cleaning, disinfection and overnight storage of contact lenses

Habitual Multi-Purpose Contact Lens Solution

Intervention Type: DEVICE

Habitual Contact Lenses

Intervention Type: DEVICE

Participant's habitual contact lens brand worn in a daily wear modality for 30 days.

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.

Group Type: OTHER

3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix

Intervention Type: DEVICE

For cleaning, disinfection and overnight storage of contact lenses

Habitual Multi-Purpose Contact Lens Solution

Intervention Type: DEVICE

Habitual Contact Lenses

Intervention Type: DEVICE

Participant's habitual contact lens brand worn in a daily wear modality for 30 days.

Interventions

3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix

For cleaning, disinfection and overnight storage of contact lenses

Intervention Type: DEVICE

Habitual Multi-Purpose Contact Lens Solution

Intervention Type: DEVICE

Habitual Contact Lenses

Participant's habitual contact lens brand worn in a daily wear modality for 30 days.

Intervention Type: DEVICE

Other Intervention Names

CLEAR CARE® PLUS

Eligibility Criteria

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;

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;

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon, a Novartis Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Project Manager, CPM

Role: STUDY_DIRECTOR

Alcon, A Novartis Division

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LCS739-P001

Identifier Type: -

Identifier Source: org_study_id