Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00768898
First received: October 6, 2008
Last updated: March 19, 2012
Last verified: March 2012
Results First Received: September 21, 2009  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Conjunctival Staining
Intervention: Other: 2.5/5.0/10.0 µL lissamine green

  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
30 subjects with conjunctival staining and no other ocular pathology were recruited and enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This reporting group includes all enrolled participants.

Reporting Groups
  Description
Overall All enrolled participants

Participant Flow:   Overall Study
    Overall  
STARTED     30  
COMPLETED     28  
NOT COMPLETED     2  
Unrelated injury                 1  
Headache                 1  



  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
Overall All enrolled participants

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Gender  
[units: participants]
 
Female     18  
Male     12  



  Outcome Measures
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1.  Primary:   Conjunctival Staining at 1 Minute   [ Time Frame: 1 minute after instillation ]

2.  Primary:   Conjunctival Staining at 2 Minutes   [ Time Frame: 2 minutes after instillation ]

3.  Primary:   Conjunctival Staining at 3 Minutes   [ Time Frame: 3 minutes after instillation ]

4.  Primary:   Conjunctival Staining at 4 Minutes   [ Time Frame: 4 minutes after instillation ]

5.  Primary:   Conjunctival Staining at 5 Minutes   [ Time Frame: 5 minutes after instillation ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alison Ramsey, O.D., Manager
Organization: Alcon Research, Ltd.
phone: 817-551-6986
e-mail: Alison.ramsey@alconlabs.com


No publications provided


Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00768898     History of Changes
Other Study ID Numbers: M-08-01
Study First Received: October 6, 2008
Results First Received: September 21, 2009
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board