The Effect of SYSTANE® BALANCE on Tear Film Break Up Time in Dry Eye Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01718028
First received: October 29, 2012
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Dry Eye
Interventions: Other: Propylene glycol 0.6% ocular emulsion
Other: Sodium chloride 0.9% saline solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 1 study center located in Argentina.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 51 enrolled, 2 participants withdrew their consent prior to receiving treatment and were exited from the study. This reporting group includes all participants who received treatment.

Reporting Groups
  Description
SYSTANE® BALANCE Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
LARMABAK® Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days

Participant Flow:   Overall Study
    SYSTANE® BALANCE     LARMABAK®  
STARTED     25     24  
COMPLETED     25     24  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
SYSTANE® BALANCE Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
LARMABAK® Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
Total Total of all reporting groups

Baseline Measures
    SYSTANE® BALANCE     LARMABAK®     Total  
Number of Participants  
[units: participants]
  25     24     49  
Age  
[units: years]
Mean ± Standard Deviation
  45.52  ± 20.06     42.96  ± 17.71     44.27  ± 18.79  
Gender  
[units: participants]
     
Female     18     15     33  
Male     7     9     16  
Region of Enrollment  
[units: participants]
     
Argentina     25     24     49  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in NITFBUT at Day 30   [ Time Frame: Baseline (Day 0), Day 30 ]

2.  Secondary:   Mean Change From Baseline in NITFBUT at Day 14   [ Time Frame: Baseline (Day 0), Day 14 ]

3.  Secondary:   Mean NITFBUT by Visit   [ Time Frame: Baseline (Day 0), Day 14, Day 30 ]

4.  Secondary:   Percent Change From Baseline in NITFBUT by Visit   [ Time Frame: Baseline (Day 0), Day 14, Day 30 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Abayomi Ogundele, Pharm.D.
Organization: Alcon Research, Ltd.
phone: 1-888-451-3937
e-mail: alcon.medinfo@alcon.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01718028     History of Changes
Other Study ID Numbers: RDG-11-262
Study First Received: October 29, 2012
Results First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: Argentina: Human Research Bioethics Committee