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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00768898
First Posted: October 8, 2008
Last Update Posted: April 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention
Conjunctival Staining Other: 2.5/5.0/10.0 µL lissamine green

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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.


Enrollment: 30
Study Start Date: August 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00768898     History of Changes
Other Study ID Numbers: M-08-01
First Submitted: October 6, 2008
First Posted: October 8, 2008
Results First Submitted: September 21, 2009
Results First Posted: April 13, 2012
Last Update Posted: April 13, 2012
Last Verified: March 2012

Keywords provided by Alcon Research:
conjunctival
staining