Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution

Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution (MPDS)

The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

Study Overview

• Status: Completed
• Conditions: Healthy Contact Lens Wearers
• Intervention / Treatment: Device: Alcon MPDS; Device: ReNu Fresh MPS

Detailed Description

The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.

• Study Type: Interventional
• Enrollment (Actual): 573
• 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: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Silicone hydrogel or soft contact lens wearers who wear their lenses daily wear (i.e. disinfect lenses every night).
• Patient must be able to read.
• Vision correctable to 20/30 or better with contact lenses.

Exclusion Criteria:

• Sensitivity to multi-purpose solutions.
• Using any topical ocular OTC or prescribed topical ocular medications.
• History or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• With a medical condition or using medications that cause ocular side effects.
• Participation in any investigational study within the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alcon MPDS; Alcon Multi-Purpose Disinfecting Solution (MPDS)	Device: Alcon MPDS; Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses; Other Names: Alcon Multi-Purpose Disinfecting Solution (MPDS)
Active Comparator: ReNu Fresh Multi-Purpose Solution	Device: ReNu Fresh MPS; ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.; Other Names: ReNu Fresh Multi-Purpose Solution (MPS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Acceptance	Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree)	Day 90

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Jessie M Lemp, MS, Alcon Research

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: April 25, 2011
• First Posted (Estimate): April 26, 2011

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Contact Lenses; Contact Lens Care; Multi-Purpose Solution
• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: C-09-026