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

Study Overview
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Brief Summary
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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.

Conditions
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Conjunctival Staining

Intervention / Treatment
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* Other: 2.5/5.0/10.0 ÂµL lissamine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: conjunctival staining Exclusion Criteria: ocular pathology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2.5 microliters lissamine green<br> | Other: 2.5/5.0/10.0 ÂµL lissamine green<br>* vital stain solution<br>|
| 5.0 microliters lissamine green<br> | Other: 2.5/5.0/10.0 ÂµL lissamine green<br>* vital stain solution<br>|
| 10.0 microliters lissamine green<br> | Other: 2.5/5.0/10.0 ÂµL lissamine green<br>* vital stain solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conjunctival, staining