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Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

Primary Purpose

Myopia, Astigmatism, Refractive Error

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPTI-FREE RepleniSH multipurpose solution
ReNu Biotrue multipurpose solution
Silicone hydrogel contact lenses
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myopia focused on measuring Soft contact lenses, Multi-purpose Solution

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Contact Alcon Trial Center for Trial Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OPTI-FREE RepleniSH

ReNu Biotrue

Arm Description

OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days

ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2010
Last Updated
October 15, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01211535
Brief Title
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Official Title
Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism, Refractive Error
Keywords
Soft contact lenses, Multi-purpose Solution

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPTI-FREE RepleniSH
Arm Type
Experimental
Arm Description
OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Arm Title
ReNu Biotrue
Arm Type
Active Comparator
Arm Description
ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
Intervention Type
Device
Intervention Name(s)
OPTI-FREE RepleniSH multipurpose solution
Other Intervention Name(s)
OPTI-FREE® RepleniSH®
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
ReNu Biotrue multipurpose solution
Other Intervention Name(s)
ReNu Biotrue™
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Silicone hydrogel contact lenses
Intervention Description
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 Outcome Measure Information:
Title
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
Description
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.
Time Frame
Baseline (Day 0), Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Contact Alcon Trial Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers

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