Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedResults Posted
Study results publicly available
April 13, 2012
CompletedApril 13, 2012
March 1, 2012
1 month
October 6, 2008
September 21, 2009
March 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Conjunctival Staining at 1 Minute
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.
1 minute after instillation
Conjunctival Staining at 2 Minutes
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.
2 minutes after instillation
Conjunctival Staining at 3 Minutes
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.
3 minutes after instillation
Conjunctival Staining at 4 Minutes
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.
4 minutes after instillation
Conjunctival Staining at 5 Minutes
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.
5 minutes after instillation
Study Arms (3)
2.5 microliters lissamine green
5.0 microliters lissamine green
10.0 microliters lissamine green
Interventions
vital stain solution
Eligibility Criteria
community sample
You may qualify if:
- conjunctival staining
You may not qualify if:
- ocular pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134, United States
Results Point of Contact
- Title
- Alison Ramsey, O.D., Manager
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2008
First Posted
October 8, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2008
Last Updated
April 13, 2012
Results First Posted
April 13, 2012
Record last verified: 2012-03