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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
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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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.

Condition or disease Intervention/treatment
Conjunctival Staining Other: 2.5/5.0/10.0 µL lissamine green

Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2008
Actual Primary Completion Date : September 2008
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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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
Study Population
community sample
Criteria

Inclusion Criteria:

  • conjunctival staining

Exclusion Criteria:

  • ocular pathology
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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