Clear Care® Plus vs. PeroxiClear™

Alcon

Status

Completed

Conditions

Refractive Error

Treatments

Device: Silicone hydrogel contact lenses

Device: PeroxiClear contact lens solution

Device: Clear Care Plus contact lens solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02413333

LCD913-P001

Details and patient eligibility

About

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.

Full description

Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.

Enrollment

133 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

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;
Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

133 participants in 2 patient groups

Clear Care Plus, then PeroxiClear

Other group

Description:

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.

Treatment:

Device: Clear Care Plus contact lens solution

Device: PeroxiClear contact lens solution

Device: Silicone hydrogel contact lenses

PeroxiClear, then Clear Care Plus

Other group

Description:

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.

Treatment:

Device: Clear Care Plus contact lens solution

Device: PeroxiClear contact lens solution

Device: Silicone hydrogel contact lenses