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OpenTrials
Completed

NCT Number: NCT02413333

Clear Care® Plus vs. PeroxiClear™

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clear Care Plus 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

PeroxiClear contact lens solution

Device

3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses

Other names: PeroxiClear

Silicone hydrogel contact lenses

Device

2-week/monthly replacement contact lenses per participant's habitual brand

Primary outcomes

  1. Mean Residual Peroxide at Day 30

    Time frame: Day 30, each product

    The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Secondary outcomes

  1. Mean Osmolality in Lens Cases at Day 30

    Time frame: Day 30, each product

    The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Osmolality was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2015
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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