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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00768898
First received: October 6, 2008
Last updated: March 19, 2012
Last verified: March 2012

October 6, 2008
March 19, 2012
August 2008
September 2008   (final data collection date for primary outcome measure)
  • Conjunctival Staining at 1 Minute [ Time Frame: 1 minute after instillation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 grading [ Time Frame: 1, 2, 3, 4, and 5 minutes after instillation ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00768898 on ClinicalTrials.gov Archive Site
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Defining the Conjunctival Staining Method: Instillation Volume and Time Course to Assess Staining With Lissamine Green
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

community sample

Conjunctival Staining
Other: 2.5/5.0/10.0 µL lissamine green
vital stain solution
  • 2.5 microliters lissamine green
    Intervention: Other: 2.5/5.0/10.0 µL lissamine green
  • 5.0 microliters lissamine green
    Intervention: Other: 2.5/5.0/10.0 µL lissamine green
  • 10.0 microliters lissamine green
    Intervention: Other: 2.5/5.0/10.0 µL lissamine green
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • conjunctival staining

Exclusion Criteria:

  • ocular pathology
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00768898
M-08-01
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP