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

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ClinicalTrials.gov Identifier: NCT01187355
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : July 30, 2012
Last Update Posted : July 30, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Symptomatic Contact Lens Wearers
Interventions Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS)
Device: renu fresh Multi-Purpose Solution (MPS)
Device: Contact lenses
Enrollment 591
Recruitment Details Subjects were recruited and enrolled from 42 US study centers.
Pre-assignment Details The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.
Arm/Group Title Alcon MPDS Renu Fresh MPS
Hide Arm/Group Description Multi-purpose disinfecting contact lens solution Multi-purpose contact lens solution
Period Title: Overall Study
Started 294 297
Completed 276 277
Not Completed 18 20
Arm/Group Title Alcon MPDS Renu Fresh MPS Total
Hide Arm/Group Description Multi-purpose disinfecting contact lens solution Multi-purpose contact lens solution Total of all reporting groups
Overall Number of Baseline Participants 288 290 578
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 288 participants 290 participants 578 participants
34.5  (11.43) 34.0  (11.24) 34.3  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 288 participants 290 participants 578 participants
Female
209
  72.6%
212
  73.1%
421
  72.8%
Male
79
  27.4%
78
  26.9%
157
  27.2%
1.Primary Outcome
Title Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed subjects with an on-regimen follow-up visit.
Arm/Group Title Alcon MPDS Renu Fresh MPS
Hide Arm/Group Description:
Multi-purpose disinfecting contact lens solution
Multi-purpose contact lens solution
Overall Number of Participants Analyzed 276 277
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.9  (0.92) 3.8  (1.05)
2.Secondary Outcome
Title Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed subjects with an on-regimen follow-up visit.
Arm/Group Title Alcon MPDS Renu Fresh MPS
Hide Arm/Group Description:
Multi-purpose disinfecting contact lens solution
Multi-purpose contact lens solution
Overall Number of Participants Analyzed 276 276
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.3  (1.12) 3.2  (1.21)
3.Secondary Outcome
Title Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.
Hide Description 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.
Time Frame Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled and dispensed subjects with an on-regimen follow-up visit.
Arm/Group Title Alcon MPDS Renu Fresh MPS
Hide Arm/Group Description:
Multi-purpose disinfecting contact lens solution
Multi-purpose contact lens solution
Overall Number of Participants Analyzed 276 277
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.2  (1.13) 3.1  (1.15)
Time Frame Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day.
Adverse Event Reporting Description This reporting group includes all subjects enrolled and dispensed test article.
 
Arm/Group Title Alcon MPDS Renu Fresh MPS
Hide Arm/Group Description Multi-purpose disinfecting contact lens solution Multi-purpose contact lens solution
All-Cause Mortality
Alcon MPDS Renu Fresh MPS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alcon MPDS Renu Fresh MPS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/292 (0.34%)      1/297 (0.34%)    
Psychiatric disorders     
Schizoaffective Disorder Bipolar Type   1/292 (0.34%)  1 0/297 (0.00%)  0
Reproductive system and breast disorders     
Abortion Spontaneous   0/292 (0.00%)  0 1/297 (0.34%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alcon MPDS Renu Fresh MPS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/292 (0.00%)      0/297 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Alcon Clinical
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: medinfo@alconlabs.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01187355     History of Changes
Other Study ID Numbers: C-09-074
First Submitted: August 20, 2010
First Posted: August 24, 2010
Results First Submitted: June 26, 2012
Results First Posted: July 30, 2012
Last Update Posted: July 30, 2012