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Acute Comfort and Blur of Systane and Optive

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00568386
First received: December 5, 2007
Last updated: January 31, 2012
Last verified: January 2012
Results First Received: December 18, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Dry Eye
Interventions: Other: Systane Lubricant Eye Drops
Other: Optive Lubricant Eye Drops

  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
Medical Clinic Nov. 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
24 hr. wash out between treatment periods

Reporting Groups
  Description
Systane Drops Then Optive Drops Systane Drops then Optive Drops
Optive Drops Then Systane Drops Optive Drops then Systane Drops

Participant Flow:   Overall Study
    Systane Drops Then Optive Drops   Optive Drops Then Systane Drops
STARTED   20   20 
COMPLETED   20   20 
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.
No text entered.

Reporting Groups
  Description
Systane Drops Then Optive Drops Systane Drops then Optive Drops
Optive Drops Then Systane Drops Optive Drops then Systane Drops
Total Total of all reporting groups

Baseline Measures
   Systane Drops Then Optive Drops   Optive Drops Then Systane Drops   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   20   20   40 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   17   17   34 
Male   3   3   6 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures

1.  Primary:   Visual Blur   [ Time Frame: 3 minutes post dose ]


  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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Research
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com



Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00568386     History of Changes
Other Study ID Numbers: M-07-02
Study First Received: December 5, 2007
Results First Received: December 18, 2008
Last Updated: January 31, 2012