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
  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 ] [ 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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768898

Locations
United States, Texas
Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00768898     History of Changes
Other Study ID Numbers: M-08-01
Study First Received: October 6, 2008
Results First Received: September 21, 2009
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
conjunctival
staining

ClinicalTrials.gov processed this record on September 18, 2014