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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2008
Last Updated Date	March 19, 2012
Start Date ^ICMJE	August 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 19, 2012)	Conjunctival Staining at 1 Minute [ Time Frame: 1 minute after instillation ] [ Designated as safety issue: No ] Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. Conjunctival Staining at 2 Minutes [ Time Frame: 2 minutes after instillation ] [ Designated as safety issue: No ] Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. Conjunctival Staining at 3 Minutes [ Time Frame: 3 minutes after instillation ] [ Designated as safety issue: No ] Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. Conjunctival Staining at 4 Minutes [ Time Frame: 4 minutes after instillation ] [ Designated as safety issue: No ] Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit. Conjunctival Staining at 5 Minutes [ Time Frame: 5 minutes after instillation ] [ Designated as safety issue: No ] Lissamine green was instilled in each eye. Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye. Each subject was represented by a single eye, referred to as the "study eye." The study eye was defined as the eye that attained the highest stain at any measurement time point during the screening visit.
Original Primary Outcome Measures ^ICMJE (submitted: October 6, 2008)	conjunctival staining grading [ Time Frame: 1, 2, 3, 4, and 5 minutes after instillation ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00768898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to determine the correct volume of lissamine green to use when assessing conjunctival staining, and to determine the time course needed to evaluate conjunctival staining after lissamine green has been instilled in the eye.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	community sample
Condition ^ICMJE	Conjunctival Staining
Intervention ^ICMJE	Other: 2.5/5.0/10.0 ÂµL lissamine green vital stain solution
Study Group/Cohort (s)	2.5 microliters lissamine green Intervention: Other: 2.5/5.0/10.0 ÂµL lissamine green 5.0 microliters lissamine green Intervention: Other: 2.5/5.0/10.0 ÂµL lissamine green 10.0 microliters lissamine green Intervention: Other: 2.5/5.0/10.0 ÂµL lissamine green
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	Not Provided
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: conjunctival staining Exclusion Criteria: ocular pathology
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00768898
Other Study ID Numbers ^ICMJE	M-08-01
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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