Alcon Multi-Purpose Disinfecting Solution Versus Renu Fresh Multi-Purpose Solution in Symptomatic Contact Lens Wearers

SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers

The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.

Study Overview

• Status: Completed
• Conditions: Symptomatic Contact Lens Wearers
• Intervention / Treatment: Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Device: Contact lenses; Device: renu fresh Multi-Purpose Solution (MPS)

• Study Type: Interventional
• Enrollment (Actual): 591
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
• Vision correctable to 20/30 or better with contact lenses.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Sensitivity to multi-purpose solutions.
• Use of any topical ocular OTC or prescribed topical ocular medications.
• History (6 months) or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• Medical condition or use of medications that cause ocular side effects.
• Participation in any investigational study within the past 30 days.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Alcon MPDS; MPDS used for 30 days as specified in protocol for contact lens care.	Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS); Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.; Device: Contact lenses; Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
ACTIVE_COMPARATOR: renu fresh MPS; MPS used for 30 days as indicated for contact lens care.	Device: Contact lenses; Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.; Device: renu fresh Multi-Purpose Solution (MPS); Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.; Other Names: renu® fresh™ Multi-Purpose Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.	Day 30
Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.	As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.	Day 30

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (ESTIMATE): August 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Multi-purpose solution; Symptomatic, Contact lens care
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: C-09-074