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

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.

Study Overview

• Status: Completed
• Conditions: Conjunctival Staining
• Intervention / Treatment: Other: 2.5/5.0/10.0 µL lissamine green

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

• conjunctival staining

Exclusion Criteria:

• ocular pathology

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Conjunctival Staining at 1 Minute	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.	1 minute after instillation
Conjunctival Staining at 2 Minutes	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 minutes after instillation
Conjunctival Staining at 3 Minutes	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 minutes after instillation
Conjunctival Staining at 4 Minutes	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 minutes after instillation
Conjunctival Staining at 5 Minutes	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 minutes after instillation

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 6, 2008
• First Submitted That Met QC Criteria: October 6, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): April 13, 2012
• Last Update Submitted That Met QC Criteria: March 19, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: conjunctival; staining
• Other Study ID Numbers: M-08-01