A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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:
Bausch & Lomb Incorporated
Information provided by:
Bausch & Lomb Incorporated
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
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 |
---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Bausch & Lomb Multi-Purpose Solution | Ciba's Multi-Purpose Solution | Total | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | William Reindel, OD, MS |
Organization: | Bausch & Lomb Incorporated |
Phone: | (585) 338-8129 |
EMail: | william.reindel@bausch.com |
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 |