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

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. Identifier: NCT00768898
Recruitment Status : Completed
First Posted : October 8, 2008
Results First Posted : April 13, 2012
Last Update Posted : April 13, 2012
Information provided by (Responsible Party):
Alcon Research

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

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
Overall All enrolled participants

Participant Flow:   Overall Study
Unrelated injury                1 
Headache                1 

  Baseline Characteristics

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
Overall All enrolled participants

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   30 
>=65 years   0 
[Units: Participants]
Female   18 
Male   12 

  Outcome Measures

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

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

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

Responsible Party: Alcon Research Identifier: NCT00768898     History of Changes
Other Study ID Numbers: M-08-01
First Submitted: October 6, 2008
First Posted: October 8, 2008
Results First Submitted: September 21, 2009
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012