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A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

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ClinicalTrials.gov Identifier: NCT01024751
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : August 11, 2011
Last Update Posted : August 15, 2011
Sponsor:
Information provided by:
Bausch & Lomb Incorporated

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition Ocular Discomfort
Interventions Device: Bausch & Lomb Multi-Purpose Solution
Device: Ciba's Multi-Purpose Solution
Enrollment 312
Recruitment Details This one month study was conducted at 20 sites by 20 investigators in the United States. First participant was enrolled 11/30/2009 and last Participants visit was 1/22/2010.
Pre-assignment Details 312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.
Arm/Group Title Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Hide Arm/Group Description Multi-Purpose Solution to be used for disinfecting contact lenses. Multi-Purpose Solution to be used for disinfecting contact lenses.
Period Title: Enrolled Participants
Started 156 156
Completed 153 152
Not Completed 3 4
Reason Not Completed
Ineligible at baseline             3             4
Period Title: Eligible Participants
Started 153 152
Completed 153 149
Not Completed 0 3
Reason Not Completed
Withdrawal by Subject             0             1
Lost to Follow-up             0             1
Ineligible             0             1
Arm/Group Title Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution Total
Hide Arm/Group Description Multi-Purpose Solution to be used for disinfecting contact lenses. Multi-Purpose Solution to be used for disinfecting contact lenses. Total of all reporting groups
Overall Number of Baseline Participants 153 152 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 18 and 70 years Number Analyzed 153 participants 152 participants 305 participants
153 152 305
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 305 participants
Female
102
  66.7%
112
  73.7%
214
  70.2%
Male
51
  33.3%
40
  26.3%
91
  29.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 305 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
   9.2%
15
   9.9%
29
   9.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   4.6%
6
   3.9%
13
   4.3%
White
131
  85.6%
126
  82.9%
257
  84.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.7%
5
   3.3%
6
   2.0%
1.Primary Outcome
Title Comfort-related Symptoms/Complaints
Hide Description Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.
Time Frame At dispensing visit and each follow-up visit at week 2 and week 4.
Hide Outcome Measure Data
Hide Analysis Population Description
Summaries included all eligible, dispensed participants, with participants summarized under the study products received.
Arm/Group Title Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Hide Arm/Group Description:
Multi-Purpose Solution to be used for disinfecting contact lenses.
Multi-Purpose Solution to be used for disinfecting contact lenses.
Overall Number of Participants Analyzed 153 151
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
306 302
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Comfort 89.0  (14.2) 88.3  (14.7)
End of Day Comfort 81.7  (20.7) 81.9  (17.4)
Burning/stinging upon insertion 91.4  (15.6) 93.1  (14.0)
Irritation 88.2  (17.1) 89.3  (14.1)
Itching 91.2  (15.8) 94.3  (10.3)
Dryness 84.9  (20.6) 85.4  (15.8)
Redness 90.7  (16.4) 92.8  (13.0)
2.Secondary Outcome
Title Slit Lamp Findings
Hide Description Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.
Time Frame Over all visits for 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Greater than grade 2 for all dispensed eyes with non-missing scores
Arm/Group Title Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Hide Arm/Group Description:
Multi-Purpose Solution to be used for disinfecting contact lenses.
Multi-Purpose Solution to be used for disinfecting contact lenses.
Overall Number of Participants Analyzed 156 153
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
312 306
Measure Type: Number
Unit of Measure: eyes
1 3
Time Frame 1 month
Adverse Event Reporting Description Adverse events measured by eye
 
Arm/Group Title Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Hide Arm/Group Description Multi-Purpose Solution to be used for disinfecting contact lenses. Multi-Purpose Solution to be used for disinfecting contact lenses.
All-Cause Mortality
Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/156 (0.00%)   0/156 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Bausch & Lomb Multi-Purpose Solution Ciba's Multi-Purpose Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/156 (0.00%)   0/156 (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.
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Reindel, OD, MS
Organization: Bausch & Lomb Incorporated
Phone: (585) 338-8129
EMail: william.reindel@bausch.com
Layout table for additonal information
Responsible Party: Mohinder Merchea, OD, PhD, MBA, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01024751    
Other Study ID Numbers: 636
First Submitted: November 30, 2009
First Posted: December 3, 2009
Results First Submitted: June 16, 2011
Results First Posted: August 11, 2011
Last Update Posted: August 15, 2011