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OpenTrials
Completed

NCT Number: NCT01211535

Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Error Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Trial Center for Trial Locations

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Currently wearing silicone hydrogel contact lenses on a daily wear basis;
  • Currently using OPTI-FREE RepleniSH contact lens solution;
  • Generally healthy;
  • Normal ocular health;
  • Willing to follow study procedures and visit schedule;
  • Sign Informed Consent and privacy document;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Use of additional lens cleaners;
  • Known sensitivities to any ingredient in either test article;
  • Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
  • History of ocular surgery/trauma within the last 6 months;
  • Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
  • Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

OPTI-FREE RepleniSH multipurpose solution

Device

FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days

Other names: OPTI-FREE® RepleniSH®

ReNu Biotrue multipurpose solution

Device

FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days

Other names: ReNu Biotrue™

Silicone hydrogel contact lenses

Device

Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care

Primary outcomes

  1. Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14

    Time frame: Baseline (Day 0), Day 14

    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." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 29, 2010
Registry last updated
Nov 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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