SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
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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: NCT01733732 |
Recruitment Status :
Completed
First Posted : November 27, 2012
Results First Posted : November 4, 2014
Last Update Posted : June 29, 2018
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Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Dry Eye Syndrome |
Interventions |
Other: SYSTANE® BALANCE Lubricant Eye Drops Other: SYSTANE® Gel |
Enrollment | 54 |
Participant Flow
Recruitment Details | Subjects were recruited from 1 study center located in the US. |
Pre-assignment Details | A total of 54 subjects were screened and randomized. This reporting group includes all randomized subjects (54). |
Arm/Group Title | Systane Balance | Systane Gel |
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One drop in each eye 4 times a day for 30 days | One drop in each eye 4 times a day for 30 days |
Period Title: Overall Study | ||
Started | 27 | 27 |
Completed | 25 | 27 |
Not Completed | 2 | 0 |
Reason Not Completed | ||
Adverse Event | 1 | 0 |
Did not attend all study visits | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Systane Balance | Systane Gel | Total | |
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One drop in each eye 4 times a day for 30 days | One drop in each eye 4 times a day for 30 days | Total of all reporting groups | |
Overall Number of Baseline Participants | 27 | 27 | 54 | |
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This analysis group includes all randomized subjects.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 27 participants | 27 participants | 54 participants | |
62.3 (14.5) | 63.8 (12.8) | 63.0 (13.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 27 participants | 27 participants | 54 participants | |
Female |
17 63.0%
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16 59.3%
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33 61.1%
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Male |
10 37.0%
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11 40.7%
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21 38.9%
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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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: | Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead |
Organization: | Alcon Research, Ltd. |
Phone: | 1-888-451-3937 |
EMail: | alcon.medinfo@alcon.com |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01733732 |
Other Study ID Numbers: |
A00976 |
First Submitted: | November 21, 2012 |
First Posted: | November 27, 2012 |
Results First Submitted: | October 29, 2014 |
Results First Posted: | November 4, 2014 |
Last Update Posted: | June 29, 2018 |