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OpenTrials
Completed

NCT Number: NCT01164865

Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

The purpose of this study was to assess comfort in soft contact lens wearers.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Wear silicone hydrogel contact lenses on a daily wear basis;
  • Currently using OPTI-FREE RepleniSH contact lens solution;
  • Report comfort above 75 on a Visual Analog Scale at the Baseline Visit;
  • Read, sign, and date IRB-approved informed consent and the privacy document;
  • Be generally healthy and have normal ocular health;
  • Be be willing to follow the study procedures and visit schedule;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Use of additional lens cleaners;
  • Known sensitivity to any ingredient in either of the test articles;
  • Systemic or ocular disease or disorder (except refractive error) that would negatively affect the conduct or outcome of the study;
  • Prior (within 7 days of enrollment) or current ocular infections;
  • Clinically significant lash or lid abnormality;
  • History of ocular surgery/trauma within the last 6 months;
  • Use of any topical ocular or systemic antibiotics or corticosteroids within 7 days of enrollment;
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

OPTI-FREE RepleniSH multipurpose disinfecting solution

Device

FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.

Other names: OPTI-FREE® RepleniSH®

Clear Care contact lens care system

Device

FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.

Other names: Clear Care®

Contact Lenses

Device

Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.

Primary outcomes

  1. Change From Baseline in Ocular Comfort Rating at 2 Weeks

    Time frame: Baseline (Day 0), 2 weeks

    Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described "how your eyes feel right now."

  2. Likert Questionnaire Scores at 2 Weeks

    Time frame: 2 weeks

    The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

The Subjective Comfort With Multipurpose and Hydrogen Peroxide Lens Care Solutions in Soft Contact Lens Wearers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 19, 2010
Registry last updated
Oct 12, 2012

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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