Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green
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ClinicalTrials.gov Identifier: NCT00768898 |
Recruitment Status
:
Completed
First Posted
: October 8, 2008
Results First Posted
: April 13, 2012
Last Update Posted
: April 13, 2012
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Condition or disease | Intervention/treatment |
---|---|
Conjunctival Staining | Other: 2.5/5.0/10.0 µL lissamine green |
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Study Start Date : | August 2008 |
Actual Primary Completion Date : | September 2008 |
Group/Cohort | Intervention/treatment |
---|---|
2.5 microliters lissamine green |
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
|
5.0 microliters lissamine green |
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
|
10.0 microliters lissamine green |
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
|
- Conjunctival Staining at 1 Minute [ Time Frame: 1 minute after instillation ]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 ]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 ]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 ]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 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- conjunctival staining
Exclusion Criteria:
- ocular pathology

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768898
United States, Texas | |
Alcon Call Center for Trial Locations | |
Fort Worth, Texas, United States, 76134 |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT00768898 History of Changes |
Other Study ID Numbers: |
M-08-01 |
First Posted: | October 8, 2008 Key Record Dates |
Results First Posted: | April 13, 2012 |
Last Update Posted: | April 13, 2012 |
Last Verified: | March 2012 |
Keywords provided by Alcon Research:
conjunctival staining |