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

Completed

• Conditions: Conjunctival Staining
• Interventions: Other: 2.5/5.0/10.0 µL lissamine green

• Registration Number: NCT00768898
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-09
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-08
• Results First Submitted: 2009-09-21
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-19
• Last Update Submitted: 2012-03-19
• Results First Posted: 2012-04-13
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• conjunctival staining

Exclusion Criteria

• ocular pathology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2.5 microliters lissamine green	2.5/5.0/10.0 µL lissamine green	-
5.0 microliters lissamine green	2.5/5.0/10.0 µL lissamine green	-
10.0 microliters lissamine green	2.5/5.0/10.0 µL lissamine green	-

Primary Outcome Measures

Name	Time	Method
Conjunctival Staining at 1 Minute	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	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	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	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	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.

Trial Locations

Locations (1)

Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States